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drospirenone, ethinyl estradiol and levomefolate calcium Kit, 3 pouches — NDC 68180-894-73 (Billing 68180-0894-73)

by Lupin Pharmaceuticals, Inc. · 3 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK

This is a package of 3 pouches of drospirenone, ethinyl estradiol and levomefolate calcium Kit from Lupin Pharmaceuticals, Inc., marketed since Aug 2018 and currently FDA-listed; retail pharmacies pay about $1.38 per pouche (NADAC). It is this product's only package size.

NDC 68180-0894-73
🏷️ FDA NDC (as labeled) 68180-894-73 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 68180-894-73 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
68180 labeler · 894 product · 73 package
Package marketed since
Aug 22, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
3 EA per package
Barcode (UPC)
0368180894711
Medicaid fills, this package
5,791 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68180-894-73
Product NDC 68180-894
11-digit billing NDC 68180089473
NCPDP billing unit EA — each (per item)
RxCUI 1013626, 1013628, 1013629
UPC 0368180894711
Application # ANDA205947
SPL Set ID 48f4301c-0426-43cd-af37-c4d8fc7aeb67
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-08-22
Dosage form KIT
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 25990003200320
GPI class Drospiren-Eth Estrad-Levomefol
GCN Seq No 066726
GCN 29095
HICL code 037200
Ingredient (HICL) Drospir/Eth Estra/Levomefol Ca
HIC1 code G
Therapeutic class — broad (HIC1) Female Genital System
HIC2 code G8
Therapeutic class — intermediate (HIC2) Systemic Antifertility Agents
HIC3 code G8A
Therapeutic class — specific (HIC3) Contraceptives,Oral
AHFS code 68:12.00.00
AHFS class Contraceptives
FDB label name DROSP-EE-LEVOMEF 3-0.02-0.451
FDB brand name Drospirenone-Eth Estra-Levomef
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 066726
  • GCN: 29095
  • GPI-14 (Medi-Span): 25990003200320
  • HICL (First Databank): 037200
  • AHFS class code: 68:12.00.00
  • RxCUI (RxNorm): 1013626
Why two NDCs? The FDA registers this code as 68180-894-73 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 68180-0894-73. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Progestin class.

Pharmacologic class Progestin
Drug family (ATC) Progestogens
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name DROSP-EE-LEVOMEF 3-0.02-0.451 Ingredient Drospir/Eth Estra/Levomefol Ca
📗 Our plain-language guide HelloPharmacist
  • It prevents pregnancy and adds folate, which lowers the risk of neural tube birth defects if you become pregnant. Beyaz and the generic versions can also treat PMDD symptoms and mo...
  • Take one pill by mouth at the same time every day, in pack order. You can take it with or without food. Take the folate-only tablets too, and start the next pack right after the la...
  • Take a single missed hormone pill as soon as you remember, then take the next at your usual time. Missing more than one means you may need back-up birth control, so check your leaf...
  • Headache, nausea, breast tenderness, and spotting are the most common. Spotting and nausea often fade within the first few packs. Call if they don't go away.
📖 Read our full Drospirenone / Ethinyl Estradiol / Levomefolate guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $1.382 $4.15 / 3 kit
Medicaid paysCMS SDUD · 12 mo $1.74 $5.22 / 3 kit
Medicare drug plans payPart D · Q2 2026 $3.11 $9.32 / 3 kit
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Aug 2022 Mar 2026 Sep 2026 $4.529 $1.252
▼ Down 68% over the last 19 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
68180-0894-73 You're viewing this Main listing 3 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK 2018-08-22 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
drospirenone, ethinyl estradiol and levomefolate calcium and levomefolate calciumthis 68180-0894-73 Lupin 3 pouches $1.382 AB Availability likely —
Tydemy 68180-0904-73 Lupin 21 tablets $2.960 AB Availability likely +114%
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2018
On the market since
Aug 2018
📍
2026
Currently FDA-listed
8 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Drospirenone / Ethinyl Estradiol / Levomefolate inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerLupin Pharmaceuticals, Inc.
Application holderLUPIN LTD
FDA applicationANDA205947 (ANDA)
Labeler code68180
First marketedAug 2018
Product typeHuman Prescription Drug
Portfolio404 products on file

More NDCs from Lupin Pharmaceuticals, Inc. labeler code 68180

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Patient Package Insert 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 123 words ▾

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke [see Contraindications ( 4 )].

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning Women over 35 years old who smoke should not use drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets. ( 4 ) Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. ( 4 )

🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS AND USAGE Drospirenone, ethinyl estradiol and levomefolate calcium tablet and levomefolate calcium tablet is a combination of drospirenone, a progestin and ethinyl estradiol, an estrogen containing a folate, indicated for use by females of reproductive potential to: Prevent pregnancy. ( 1.1 ) Treat symptoms of premenstrual dysphoric disorder (PMDD) for females of reproductive potential who choose to use an oral contraceptive for contraception. ( 1.2 ) Treat moderate acne for females of reproductive potential at least 14 years old only if the patient desires an oral contraceptive for birth control.

( 1.3 ) Raise folate levels in females of reproductive potential who choose to use an oral contraceptive for contraception. ( 1.4 )

1.1Oral Contraceptive Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets are indicated for use by females of reproductive potential to prevent pregnancy.

1.2Premenstrual Dysphoric Disorder (PMDD) Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets are also indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in females of reproductive potential who choose to use an oral contraceptive as their method of contraception. The effectiveness of drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets for PMDD when used for more than three menstrual cycles has not been evaluated.

The essential features of PMDD according to the Diagnostic and Statistical Manual-4th edition (DSM-IV) include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain.

In this disorder, these symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school, or with usual social activities and relationships with others. Diagnosis is made by healthcare providers according to DSM-IV criteria, with symptomatology assessed prospectively over at least two menstrual cycles. In making the diagnosis, care should be taken to rule out other cyclical mood disorders.

Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets has not been evaluated for the treatment of premenstrual syndrome (PMS).

1.3Acne Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets are indicated for the treatment of moderate acne vulgaris in females of reproductive potential at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.

1.4Folate Supplementation Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets are indicated in females of reproductive potential who choose to use an oral contraceptive as their method of contraception, to raise folate levels for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Take one tablet daily by mouth at the same time every day. ( 2.1 ) Tablets must be taken in the order directed on the blister. ( 2.1 )

2.1How to Take Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets and Levomefolate Calcium Tablets Take one tablet by mouth at the same time every day. The failure rate may increase when pills are missed or taken incorrectly. To achieve maximum contraceptive and PMDD effectiveness, drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets must be taken as directed, in the order directed on the blister.

Single missed pills should be taken as soon as remembered.

2.2How to Start Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets and Levomefolate Calcium Tablets Instruct the patient to begin taking drospirenone, ethinyl estradiol and levomefolate calcium tablets either on the first day of her menstrual period (Day 1 Start) or on the first Sunday after the onset of her menstrual period (Sunday Start). Day 1 Start During the first cycle of drospirenone, ethinyl estradiol and levomefolate calcium tablets use, instruct the patient to take one pink drospirenone, ethinyl estradiol and levomefolate calcium tablet daily, beginning on Day 1 of her menstrual cycle.

(The first day of menstruation is Day 1.) She should take one pink drospirenone, ethinyl estradiol and levomefolate calcium tablet daily for 24 consecutive days, followed by one light orange tablet daily on Days 25 through 28. Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid, as needed. Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets can be taken without regard to meals.

If drospirenone, ethinyl estradiol and levomefolate calcium tablet and levomefolate calcium tablet is first taken later than the first day of the menstrual cycle, drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.

Sunday Start During the first cycle of drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets use, instruct the patient to take one pink drospirenone, ethinyl estradiol and levomefolate calcium tablet daily, beginning on the first Sunday after the onset of her menstrual period. She should take one pink drospirenone, ethinyl estradiol and levomefolate calcium tablet daily for 24 consecutive days, followed by one light orange tablet daily on Days 25 through 28. Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid, as needed.

Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets can be taken without regard to meals. Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days.

The possibility of ovulation and conception prior to initiation of medication should be considered. The patient should begin her next and all subsequent 28-day regimens of drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets on the same day of the w… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 129 words ▾

3 DOSAGE FORMS AND STRENGTHS Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets are available in blister containing 28 tablets packed in a pouch. Such three pouches are packaged in a carton. Each blister contains 28 film-coated, round, biconvex tablets in the following order: 24 pink tablets each containing 3 mg drospirenone (DRSP), 0.02 mg ethinyl estradiol (EE) and 0.451 mg levomefolate calcium 4 light orange tablets each containing 0.451 mg levomefolate calcium Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets consist of 28 film-coated, biconvex tablets in the following order ( 3 ): 24 pink tablets, each containing 3 mg drospirenone (DRSP), 0.02 mg ethinyl estradiol (EE) and 0.451 mg levomefolate calcium 4 light orange tablets, each containing 0.451 mg levomefolate calcium

⛔ Contraindications ~2 min read ▾

4 CONTRAINDICATIONS Drospirenone, ethinyl estradiol and levomefolate calcium tablet and levomefolate calcium tablet is contraindicated in females who are known to have or develop the following conditions: Renal impairment Adrenal insufficiency A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: Smoke, if over age 35 [see Boxed Warning and Warnings And Precautions ( 5.1 )] Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings And Precautions ( 5.1 )] Have cerebrovascular disease [see Warnings And Precautions ( 5.1 )] Have coronary artery disease [see Warnings And Precautions ( 5.1 )] Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings And Precautions ( 5.1 )] Have inherited or acquired hypercoagulopathies [see Warnings And Precautions ( 5.1 )] Have uncontrolled hypertension [see Warnings And Precautions ( 5.6 )] Have diabetes mellitus with vascular disease [see Warnings And Precautions ( 5.8 )] Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 [see Warnings And Precautions ( 5.9 )] Undiagnosed abnormal uterine bleeding [see Warnings And Precautions ( 5.10 )] Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see Warnings And Precautions ( 5.3 )] Liver tumors, benign or malignant, or liver disease [see Warnings And Precautions ( 5.4 ) and Use In Specific Populations ( 8.7 )] Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir due to the potential for ALT elevations [see Warnings And Precautions ( 5.5 ) and Drug Interactions ( 7.3 )].

Renal impairment ( 4 ) Adrenal insufficiency ( 4 ) A high risk of arterial or venous thrombotic diseases ( 4 ) Undiagnosed abnormal uterine bleeding ( 4 ) Breast cancer ( 4 ) Liver tumors or liver disease ( 4 ) Co-administration with Hepatitis C drug combinations containing ombitasvir, paritaprevir/ritonavir, with or without dasabuvir ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Vascular risks : Stop drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets if a thrombotic event occurs. Stop at least 4 weeks before and through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding.

( 5.1 ) COCs containing DRSP may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing levonorgestrel or some other progestins. Before initiating drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets in a new COC user or a woman who is switching from a contraceptive that does not contain DRSP, consider the risks and benefits of a DRSP-containing COC in light of her risk of a VTE. ( 5.1 ) Hyperkalemia : DRSP has anti-mineralocorticoid activity.

Do not use in patients predisposed to hyperkalemia. Check serum potassium concentration during the first treatment cycle in women on long-term treatment with medications that may increase serum potassium concentration. ( 5.2 , 7.1 , 7.2 ) Liver disease : Discontinue Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets if jaundice occurs.

( 5.4 ) High blood pressure : Do not prescribe drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets for women with uncontrolled hypertension or hypertension with vascular disease. ( 5.6 ) Carbohydrate and lipid metabolic effects : Monitor prediabetic and diabetic women taking drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia.

( 5.8 ) Headache : Evaluate significant change in headaches and discontinue drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets if indicated. ( 5.9 ) Uterine bleeding : Evaluate irregular bleeding or amenorrhea. ( 5.10 )

5.1Thromboembolic Disorders and Other Vascular Problems Stop drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets if an arterial or venous thrombotic (VTE) event occurs. Based on presently available information on DRSP-containing COCs with 0.03 mg ethinyl estradiol (that is, Yasmin ® ), DRSP-containing COCs may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing the progestin levonorgestrel or some other progestins. Epidemiologic studies that compared the risk of VTE reported that the risk ranged from no increase to a three-fold increase.

Before initiating use of drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets in a new COC user or a woman who is switching from a contraceptive that does not contain DRSP, consider the risks and benefits of a DRSP-containing COC in light of her risk of a VTE. Known risk factors for VTE include smoking, obesity, and family history of VTE, in addition to other factors that contraindicate use of COCs [see Contraindications ( 4 )]. A number of studies have compared the risk of VTE for users of Yasmin ® (which contains 0.03 mg of EE and 3 mg of DRSP) to the risk for users of other COCs, including COCs containing levonorgestrel.

Those that were required or sponsored by regulatory agencies are summarized in Table 2 Table 2: Estimates (Hazard Ratios) of Venous Thromboembolism Risk in Current Users of Yasmin ® Compared to Users of Oral Contraceptives that Contain Other Progestins Epidemiologic Study (Author, Year of Publication) Population Studied Comparator Product (all are low-dose COCs; with ≤ 0.04 mg of EE) Hazard Ratio (HR) (95% CI) i3 Ingenix (Seeger 2007) Initiators, including new users "New users" - no use of combination hormonal contraception for at least the prior 6 months All COCs available in the US during the conduct of the study Includes low-dose COCs containing the following progestins: norg… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: Serious cardiovascular events and stroke [see Boxed Warning and Warnings And Precautions ( 5.1 )] Vascular events [see Warnings And Precautions ( 5.1 )] Liver disease [see Warnings And Precautions ( 5.4 )] The most frequent adverse reactions (≥2%) in contraception, acne and folate clinical trials are headache/migraine (5.9%), menstrual irregularities (4.1%), nausea/vomiting (3.5%) and breast pain/tenderness (3.2%).

( 6.1 ) The most frequent adverse reactions (≥2%) in PMDD clinical trials are menstrual irregularities (24.9%), nausea (15.8%), headache (13.0%), breast tenderness (10.5%), fatigue (4.2%), irritability (2.8%), decreased libido (2.8%), increased weight (2.5%), and affect lability (2.1%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in practice. Contraception, Acne and Folate Supplementation Clinical Trials The data provided reflect the experience with the use of YAZ ® (3 mg DRSP/0.02 mg EE), in the adequate and well-controlled studies for contraception (N=1,056), for moderate acne vulgaris (N=536) and folate supplementation (N=379).

For contraception, a Phase 3, multicenter, multinational, open-label study was conducted to evaluate safety and efficacy up to one year in 1,027 women aged 17 to 36 who took at least one dose of YAZ ® . A second Phase 3 study was a single center, open-label, active-controlled study to evaluate the effect of 7 28-day cycles of YAZ ® on carbohydrate metabolism, lipids and hemostasis in 29 women aged 18 to 35. For acne, two multicenter, double-blind, randomized, placebo-controlled studies, in 536 women aged 14 to 45 with moderate acne vulgaris who took at least one dose of YAZ ® , evaluated the safety and efficacy during up to 6 cycles.

For folate supplementation, the primary efficacy study using drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets was a multicenter, double-blind, randomized, active-controlled US trial in 379 healthy women aged 18 to 40 who were treated with drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets or YAZ ® for up to 24 weeks. The adverse reactions seen across the 3 indications overlapped, and are reported using the frequencies from the pooled dataset.

The most common adverse reactions (≥2% of users) were: headache/migraine (5.9%), menstrual irregularities (including vaginal hemorrhage [primarily spotting], metrorrhagia and menorrhagia) (4.1%), nausea/vomiting (3.5%), and breast pain/tenderness (3.2%). PMDD Clinical Trials Safety data from trials for the indication of PMDD are reported separately due to differences in study design and setting in the OC, Acne and Folate Supplementation studies as compared to the PMDD clinical program. Two (one parallel and one crossover designed) multicenter, double-blind, randomized, placebo-controlled trials for the secondary indication of treating the symptoms of PMDD evaluated safety and efficacy of YAZ ® during up to 3 cycles among 285 women aged 18 to 42, diagnosed with PMDD and who took at least one dose of YAZ ® .

Common adverse reactions (≥2% of users) were: menstrual irregularities (including vaginal hemorrhage [primarily spotting] and metrorrhagia) (24.9%), nausea (15.8%), headache (13.0%), breast tenderness (10.5%), fatigue (4.2%), irritability (2.8%), decreased libido (2.8%), increased weight (2.5%), and affect lability (2.1%). Adverse Reactions (≥1%) Leading to Study Discontinuation Contraception Clinical Trials: Of 1,056 women, 6.6% discontinued from the clinical trials… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. Drugs or herbal products that induce certain enzymes (for example, CYP3A4) may decrease the effectiveness of COCs or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with COCs.

( 7.1 )

7.1Effects of Other Drugs on Combined Oral Contraceptives Substances Diminishing the Efficacy of COCs Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the effectiveness of COCs or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampin, topiramate and products containing St. John's wort.

Interactions between oral contraceptives and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Counsel women to use an alternative method of contraception or a back-up method when enzyme inducers are used with COCs, and to continue back-up contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability. Substances Increasing the Plasma Concentrations of COCs Co-administration of atorvastatin and certain COCs containing EE increase AUC values for EE by approximately 20%.

Ascorbic acid and acetaminophen may increase plasma EE concentrations, possibly by inhibition of conjugation. Concomitant administration of moderate or strong CYP3A4 inhibitors such as azole antifungals (e.g., ketoconazole, itraconazole, voriconazole, fluconazole), verapamil, macrolides (e.g., clarithromycin, erythromycin), diltiazem, and grapefruit juice can increase the plasma concentrations of the estrogen or the progestin or both. In a clinical drug-drug interaction study conducted in premenopausal women, once daily co-administration of DRSP 3 mg/EE 0.02 mg containing tablets with strong CYP3A4 inhibitor, ketoconazole 200 mg twice daily for 10 days resulted in a moderate increase of DRSP systemic exposure.

The exposure of EE was increased mildly [see Warnings And Precautions ( 5.2 ) And Clinical Pharmacology ( 12.3 )]. Human Immunodeficiency Virus (HIV)/ Hepatitis C Virus (HCV) Protease Inhibitors and Non-Nucleoside Reverse Transcriptase Inhibitors Significant changes (increase or decrease) in the plasma concentrations of estrogen and progestin have been noted in some cases of co-administration with HIV/HCV protease inhibitors or with non-nucleoside reverse transcriptase inhibitors. Antibiotics There have been reports of pregnancy while taking hormonal contraceptives and antibiotics, but clinical pharmacokinetic studies have not shown consistent effects of antibiotics on plasma concentrations of synthetic steroids.

7.2Effects of Combined Oral Contraceptives on Other Drugs COCs containing EE may inhibit the metabolism of other compounds. COCs have been shown to significantly decrease plasma concentrations of lamotrigine, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.

Consult the labeling of the concurrently-used drug to obtain further information about interactions with COCs or the potential for enzyme alterations. COCs Increasing the Plasma Concentrations of CYP450 Enzymes In clinical studies, administration of a hormonal contraceptive containing EE did not lead to any increase or only to a weak increase in plasma concentrations of CYP3A4 substrates (e.g., midazolam) while plasma concentrations of CYP2C19 substrates (e.g., omeprazole and voriconazole) and CYP1A2 substrates (e.g., theophylline and tizanidine) can have a weak or moderate increase.

Clinical studies did not indicate an inhibitory potential of DRSP towards human… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Can reduce milk production in breast-feeding females. ( 8.2 )

8.1Pregnancy Risk Summary There is no use for contraception in pregnancy; therefore, Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets should be discontinued during pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to CHCs before conception or during early pregnancy. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively.

Data Human Data A retrospective database study of women in Norway, that included 44,734 pregnancies of which 368 were women who inadvertently took drospirenone/ethinyl estradiol during the first trimester of a pregnancy, found there were no adverse effects on pre-term birth, small for gestational age, or birth weight Z-scores. Post-marketing adverse event data on the use of drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets in pregnant women suggest that frequencies of miscarriage and congenital anomalies were not higher than the estimated background risk in the general population.

8.2Lactation Risk Summary DRSP is present in human milk. After a single oral administration of 3 mg DRSP/0.03 mg EE tablets, DRSP concentration in breast milk over the 24-h period ranged from 1.4 to 7.0 ng/mL, with a mean ± standard deviation value of 3.7 ± 1.9 ng/mL. The estimated mean infant dose was 0.003 mg/day, which is about 0.1% of maternal dose (see Data).

There is limited information on the effects of drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets on the breast-fed infant. CHCs can reduce milk production in breast- feeding females. This reduction can occur at any time but is less likely to occur once breast-feeding is well-established.

When possible, advise the nursing female to use other methods of contraception until she discontinues breast-feeding. [See also Dosage and Administration (2.2)]. Increase in folate concentration in milk is not expected (see Data). The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets and any potential adverse effects on the breast-fed child from drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets or from the underlying maternal condition.

Data Human Data An open-label study evaluated the degree of DRSP transfer into milk within 72 hours following a single oral administration of 3 mg DRSP/0.03 mg EE tablets to 6 healthy lactating women who were 1 week to 3 months post-partum. DRSP was present in breast milk with a mean Cmax of 13.5 ng/mL, while the mean Cmax in serum of lactating women was 30.8 ng/mL. The DRSP concentration in breast milk over the 24-hour period following dosing ranged from 1.4 to 7.0 ng/mL, with a mean ± standard deviation value of 3.7 ± 1.9 ng/mL.

Based on single dose data, the maximal daily infant dose of DRSP was calculated to be 0.003 mg/day, which represented a mean of 0.1% of the maternal dose. A study in approximately 60 lactating women demonstrated no significant differences in folate concentrations in milk between women who received 416mcg/day [6S]-5-methyltetrahydrofolate or 400 mcg/day folic acid and women who received placebo over a 16 week period. Studies to date indicate there is no adverse effect of folate on nursing infants.

8.4Pediatric Use Safety and efficacy of drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets has been established in women of reproductive age. Efficacy is expe… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy 182 words ▾

8.1Pregnancy Risk Summary There is no use for contraception in pregnancy; therefore, Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets should be discontinued during pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to CHCs before conception or during early pregnancy. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively.

Data Human Data A retrospective database study of women in Norway, that included 44,734 pregnancies of which 368 were women who inadvertently took drospirenone/ethinyl estradiol during the first trimester of a pregnancy, found there were no adverse effects on pre-term birth, small for gestational age, or birth weight Z-scores. Post-marketing adverse event data on the use of drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets in pregnant women suggest that frequencies of miscarriage and congenital anomalies were not higher than the estimated background risk in the general population.

🧒 Pediatric Use 57 words ▾

8.4Pediatric Use Safety and efficacy of drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets has been established in women of reproductive age. Efficacy is expected to be the same for postpubertal adolescents under the age of 18 and for users 18 years and older. Use of this product before menarche is not indicated.

🧓 Geriatric Use 28 words ▾

8.5Geriatric Use Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets has not been studied in postmenopausal women and is not indicated in this population.

🆘 Overdosage 88 words ▾

10 OVERDOSAGE There have been no reports of serious ill effects from overdose, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea. DRSP is a spironolactone analogue which has anti-mineralocorticoid properties.

Serum concentration of potassium and sodium, and evidence of metabolic acidosis, should be monitored in cases of overdose. Levomefolate calcium doses of 17 mg/day (37-fold higher than the levomefolate calcium dose of drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets) were well tolerated after long-term treatment up to 12 weeks.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1MECHANISM OF ACTION COCs lower the risk of becoming pregnant primarily by suppressing ovulation.

12.2PHARMACODYNAMICS Drospirenone is a spironolactone analogue with anti-mineralocorticoid and antiandrogenic activity. The estrogen in drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets is ethinyl estradiol (EE). Contraception No specific pharmacodynamic studies were conducted with drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets.

Two studies evaluated the effect of 3 mg DRSP / 0.02 mg EE combinations on the suppression of ovarian activity as assessed by measurement of follicle size via transvaginal ultrasound and serum hormone (progesterone and estradiol) analyses during two treatment cycles (21-day active tablet period plus 7-day pill-free period). More than 90% of subjects in these studies demonstrated ovulation inhibition. One study compared the effect of 3 mg DRSP/0.02 mg EE combinations with two different regimens (24-day active tablet period plus 4-day pill-free period vs.

21-day active tablet period plus 7-day pill-free period) on the suppression of ovarian activity during two treatment cycles. During the first treatment cycle, there were no subjects (0/49, 0%) taking the 24-day regimen who ovulated compared to 1 subject (1/50, 2%) using the 21-day regimen. After intentionally introduced dosing errors (3 missed active tablets on Days 1 to 3) during the second treatment cycle, there was 1 subject (1/49, 2%) taking the 24-day regimen who ovulated compared to 4 subjects (4/50, 8%) using the 21-day regimen.

Acne Acne vulgaris is a skin condition with a multifactorial etiology including androgen stimulation of sebum production. While the combination of EE and DRSP increases sex hormone binding globulin (SHBG) and decreases free testosterone, the relationship between these changes and a decrease in the severity of facial acne in otherwise healthy women with this skin condition has not been established. The impact of the antiandrogenic activity of DRSP on acne is not known.

Folate Supplementation Two studies evaluated the impact of drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets on plasma folate and RBC folate levels. A randomized, double-blind, active-controlled, parallel group study compared plasma folate and red blood cell (RBC) folate levels during a 24-week treatment with YAZ ® + 0.451 mg levomefolate calcium as compared to YAZ ® alone in a U.S. population. The pharmacodynamic effect on plasma folate, RBC folate, and the profile of circulating folate metabolites was assessed during 24 weeks of treatment with 0.451 mg levomefolate calcium or with 0.4 mg folic acid (equimolar dose to 0.451 mg levomefolate calcium), both in combination with 3 mg DRSP/0.03 mg EE (Yasmin ® ) followed by 20 weeks of open-label treatment with Yasmin ® only (elimination phase). [see Clinical Studies ( 14.4 ).]

12.3PHARMACOKINETICS Absorption Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets and YAZ ® are bioequivalent with respect to DRSP and EE. The absolute bioavailability of DRSP from a single entity tablet is about 76%. The absolute bioavailability of EE is approximately 40% as a result of presystemic conjugation and first-pass metabolism.

The absolute bioavailability of drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets, which is combination tablets of DRSP and EE has not been evaluated. Serum concentrations of DRSP and EE reached peak levels within 1 to 2 hours after administration of drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets. The pharmacokinetics of DRSP are dose proportional following single doses ranging from 1 to 10 mg.

Following daily dosing of YAZ ® , steady state DRSP concentrations were observed after 8 days. The… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 15 words ▾

12.1MECHANISM OF ACTION COCs lower the risk of becoming pregnant primarily by suppressing ovulation.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets are available in 28 tablets blister containing 28 tablets packed in a pouch (NDC 68180-894-71). Such three pouches are packaged in a carton (NDC 68180-894-73). Each blister contains 28 film-coated tablets in the following order: 24 pink, round shaped, biconvex film-coated tablets debossed with "LU" on one side and "J61" on other side each containing 3 mg drospirenone, 0.02 mg ethinyl estradiol and 0.451 mg levomefolate calcium.

4 light orange, round shaped, biconvex film-coated tablets debossed with "LU" on one side and "J62" on other side each containing 0.451 mg levomefolate calcium.

16.2Storage Store at 25 ° C (77 ° F); excursions permitted to 15 ° to 30 ° C (59 ° to 86 ° F) [See USP Controlled Room Temperature].

16.1How Supplied Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets are available in 28 tablets blister containing 28 tablets packed in a pouch (NDC 68180-894-71). Such three pouches are packaged in a carton (NDC 68180-894-73). Each blister contains 28 film-coated tablets in the following order: 24 pink, round shaped, biconvex film-coated tablets debossed with "LU" on one side and "J61" on other side each containing 3 mg drospirenone, 0.02 mg ethinyl estradiol and 0.451 mg levomefolate calcium.

4 light orange, round shaped, biconvex film-coated tablets debossed with "LU" on one side and "J62" on other side each containing 0.451 mg levomefolate calcium.

📋 Description ~1 min read ▾

11 DESCRIPTION Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets provide an oral contraceptive regimen consisting of 28 film-coated tablets that contain the active ingredients specified for each tablet below: 24 pink tablets each containing 3 mg DRSP, 0.02 mg EE, and 0.451 mg levomefolate calcium 4 light orange tablets each containing 0.451 mg levomefolate calcium The inactive ingredients in the pink tablets are ascorbic acid, corn starch, croscarmellose sodium, ferric oxide red, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, polyethylene glycol, pregelatinized starch, talc and titanium dioxide.

The light orange film-coated tablets contain 0.451 mg of levomefolate calcium. The inactive ingredients in the light orange tablets are ascorbic acid, corn starch, croscarmellose sodium, ferric oxide yellow, ferric oxide red, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, polyethylene glycol, pregelatinized starch, talc and titanium dioxide. Drospirenone ((2', S ,6 R ,7 R ,8 R ,9 S ,10 R ,13 S ,14 S ,15 S ,16 S )-1,3',4',6,7,8,9,10,11,12,13,14,15, 16,20,21-Hexadecadydro-10,13-dimethylspirol[17 H -dicyclopropa [6,7:15,16] cyclopenta [a] phenanthrene-17, 2', (5' H )-furan] -3, 5' (2 H ) dione is a synthetic progestational compound and has a molecular weight of 366.49 and a molecular formula of C 24 H 30 O 3 .

Ethinyl estradiol 19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol is a synthetic estrogenic compound and has a molecular weight of 296.40 and a molecular formula of C 20 H 24 O 2 . Levomefolate calcium N-{4-[[((6S)-2-amino-3,4,5,6,7,8-hexahydro-5-methyl-4-oxo-6-pteridinyl) methyl] amino] benzoyl}-L-glutamic acid, calcium salt is a synthetic calcium salt of L-5-methyltetrahydrofolate (L-5-methyl-THF), which is a metabolite of vitamin B 9 and has a molecular weight of 497.5 and a molecular formula of C 20 H 23 CaN 7 O 6 .

The structural formulas are as follows: Drospirenone Ethinyl Estradiol Levomefolate Calcium Image Image Image

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the "FDA-approved patient labeling (Patient Information)." Counsel patients that cigarette smoking increases the risk of serious cardiovascular events from COC use, and that women who are over 35 years old and smoke should not use COCs. Counsel patients that the increased risk of VTE compared to non-users of COCs is greatest after initially starting a COC or restarting (following a 4-week or greater pill-free interval) the same or a different COC. Counsel patients about the information regarding the risk of VTE with DRSP-containing COCs compared to COCs that contain levonorgestrel or some other progestins.

Counsel patients that drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets does not protect against HIV-infection (AIDS) and other sexually transmitted diseases. Counsel patients on Warnings and Precautions associated with COCs. Counsel patients that drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets contains DRSP.

Drospirenone may increase potassium. Patients should be advised to inform their healthcare provider if they have kidney, liver or adrenal disease because the use of drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets in the presence of these conditions could cause serious heart and health problems. They should also inform their healthcare provider if they are currently on daily, long-term treatment (NSAIDs, potassium-sparing diuretics, potassium supplementation, ACE inhibitors, angiotensin-II receptor antagonists, heparin or aldosterone antagonists) for a chronic condition or taking strong CYP3A4 inhibitors.

Inform patients that drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets are not indicated during pregnancy. If pregnancy occurs during treatment with drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets, instruct the patient to stop further intake. However, women should be advised on the continued need of sufficient folate intake.

Counsel patients to take one tablet daily by mouth at the same time every day. Instruct patients what to do in the event pills are missed. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with COCs.

Counsel patients who are breastfeeding or who desire to breastfeed that COCs may reduce breast milk production. This is less likely to occur if breastfeeding is well established. Counsel any patient who starts COCs postpartum, and who has not yet had a period, to use an additional method of contraception until she has taken a pink tablet for 7 consecutive days.

Counsel patients that amenorrhea may occur. Rule out pregnancy in the event of amenorrhea in two or more consecutive cycles. Counsel patients to report whether they are taking folate supplements. drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets contains the equivalent of 0.4mg (400 mcg) of folic acid.

Counsel patients to maintain folate supplementation if they discontinue drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets due to pregnancy. ®The brands listed are trademarks of their respective owners and are not trademarks of Lupin Pharmaceuticals, Inc. The makers of these brands are not affiliated with and do not endorse Lupin Pharmaceuticals, Inc. or its products. Distributed by: Lupin Pharmaceuticals, Inc.

Naples, FL 34108 United States Manufactured by: Lupin Limited Pithampur (M.P.) - 454 775 India Revised: December 2024 IMAGE trade mark

🍼 Nursing Mothers ~2 min read ▾

8.2Lactation Risk Summary DRSP is present in human milk. After a single oral administration of 3 mg DRSP/0.03 mg EE tablets, DRSP concentration in breast milk over the 24-h period ranged from 1.4 to 7.0 ng/mL, with a mean ± standard deviation value of 3.7 ± 1.9 ng/mL. The estimated mean infant dose was 0.003 mg/day, which is about 0.1% of maternal dose (see Data).

There is limited information on the effects of drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets on the breast-fed infant. CHCs can reduce milk production in breast- feeding females. This reduction can occur at any time but is less likely to occur once breast-feeding is well-established.

When possible, advise the nursing female to use other methods of contraception until she discontinues breast-feeding. [See also Dosage and Administration (2.2)]. Increase in folate concentration in milk is not expected (see Data). The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets and any potential adverse effects on the breast-fed child from drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets or from the underlying maternal condition.

Data Human Data An open-label study evaluated the degree of DRSP transfer into milk within 72 hours following a single oral administration of 3 mg DRSP/0.03 mg EE tablets to 6 healthy lactating women who were 1 week to 3 months post-partum. DRSP was present in breast milk with a mean Cmax of 13.5 ng/mL, while the mean Cmax in serum of lactating women was 30.8 ng/mL. The DRSP concentration in breast milk over the 24-hour period following dosing ranged from 1.4 to 7.0 ng/mL, with a mean ± standard deviation value of 3.7 ± 1.9 ng/mL.

Based on single dose data, the maximal daily infant dose of DRSP was calculated to be 0.003 mg/day, which represented a mean of 0.1% of the maternal dose. A study in approximately 60 lactating women demonstrated no significant differences in folate concentrations in milk between women who received 416mcg/day [6S]-5-methyltetrahydrofolate or 400 mcg/day folic acid and women who received placebo over a 16 week period. Studies to date indicate there is no adverse effect of folate on nursing infants.

🧬 Pharmacokinetics ~3 min read ▾

12.3PHARMACOKINETICS Absorption Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets and YAZ ® are bioequivalent with respect to DRSP and EE. The absolute bioavailability of DRSP from a single entity tablet is about 76%. The absolute bioavailability of EE is approximately 40% as a result of presystemic conjugation and first-pass metabolism.

The absolute bioavailability of drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets, which is combination tablets of DRSP and EE has not been evaluated. Serum concentrations of DRSP and EE reached peak levels within 1 to 2 hours after administration of drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets. The pharmacokinetics of DRSP are dose proportional following single doses ranging from 1 to 10 mg.

Following daily dosing of YAZ ® , steady state DRSP concentrations were observed after 8 days. There was about 2 to 3 fold accumulation in serum C max and AUC (0 to 24h) values of DRSP following multiple dose administration of YAZ ® (see Table 3). For EE, steady-state conditions are reported during the second half of a treatment cycle.

Following daily administration of YAZ ® , serum C max and AUC (0 to 24h) values of EE accumulate by a factor of about 1.5 to 2 (see Table 3). Levomefolate calcium is structurally identical to L-5-methyltetrahydrofolate (L-5-methyl-THF), a metabolite of vitamin B 9 . Mean baseline concentrations of about 15 nmol/L are reached in populations without folate food fortification under normal nutritional conditions.

Orally administered levomefolate calcium is absorbed and incorporated into the body folate pool. Peak plasma concentrations of about 50 nmol/L above baseline are reached within 0.5 to 1.5 hours after single oral administration of 0.451 mg levomefolate calcium. Steady state conditions for total folate in plasma after intake of 0.451 mg levomefolate calcium are reached after about 8 to 16 weeks depending on the baseline levels.

In red blood cells achievement of steady state is delayed due to the long life-span of red blood cells of about 120 days. Table 3: Pharmacokinetic Parameters of YAZ ® (DRSP 3 mg and EE 0.02 mg) DRSP Cycle/Day No. of Subjects C max geometric mean (geometric coefficient of variation) (ng/mL) T max median (range) (h) AUC(0 to 24h) (ng . h/mL) t 1/2 (h) 1/1 23 38.4 (25) 1.5 (1 to 2) 268 (19) NA NA = Not available 1/21 23 70.3 (15) 1.5 (1 to 2) 763 (17) 30.8 (22) EE Cycle/Day No. of Subjects C max (pg/mL) T max (h) AUC(0 to 24h) (pg . h/mL) t 1/2 (h) 1/1 23 32.8 (45) 1.5 (1 to 2) 108 (52) NA 1/21 23 45.1 (35) 1.5 (1 to 2) 220 (57) NA Food Effect The rate of absorption of DRSP and EE following single administration of a formulation similar to drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets was slower under fed (high fat meal) conditions with the serum C max being reduced about 40% for both components.

The extent of absorption of DRSP, however, remained unchanged. In contrast, the extent of absorption of EE was reduced by about 20% under fed conditions. The effect of food on absorption of levomefolate calcium following administration of drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets has not been evaluated.

Distribution DRSP and EE serum concentrations decline in two phases. The apparent volume of distribution of DRSP is approximately 4 L/kg and that of EE is reported to be approximately 4 to 5 L/kg. DRSP does not bind to sex hormone binding globulin (SHBG) or corticosteroid binding globulin (CBG) but binds about 97% to other serum proteins.

Multiple dosing over 3 cycles resulted in no change in the free fraction (as measured at trough concentrations). EE is reported to be highly but non-specifically bound to serum albumin (approximately 98.5 %) and induces an increase in the serum concentrations of both SHBG… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics ~2 min read ▾

12.2PHARMACODYNAMICS Drospirenone is a spironolactone analogue with anti-mineralocorticoid and antiandrogenic activity. The estrogen in drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets is ethinyl estradiol (EE). Contraception No specific pharmacodynamic studies were conducted with drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets.

Two studies evaluated the effect of 3 mg DRSP / 0.02 mg EE combinations on the suppression of ovarian activity as assessed by measurement of follicle size via transvaginal ultrasound and serum hormone (progesterone and estradiol) analyses during two treatment cycles (21-day active tablet period plus 7-day pill-free period). More than 90% of subjects in these studies demonstrated ovulation inhibition. One study compared the effect of 3 mg DRSP/0.02 mg EE combinations with two different regimens (24-day active tablet period plus 4-day pill-free period vs.

21-day active tablet period plus 7-day pill-free period) on the suppression of ovarian activity during two treatment cycles. During the first treatment cycle, there were no subjects (0/49, 0%) taking the 24-day regimen who ovulated compared to 1 subject (1/50, 2%) using the 21-day regimen. After intentionally introduced dosing errors (3 missed active tablets on Days 1 to 3) during the second treatment cycle, there was 1 subject (1/49, 2%) taking the 24-day regimen who ovulated compared to 4 subjects (4/50, 8%) using the 21-day regimen.

Acne Acne vulgaris is a skin condition with a multifactorial etiology including androgen stimulation of sebum production. While the combination of EE and DRSP increases sex hormone binding globulin (SHBG) and decreases free testosterone, the relationship between these changes and a decrease in the severity of facial acne in otherwise healthy women with this skin condition has not been established. The impact of the antiandrogenic activity of DRSP on acne is not known.

Folate Supplementation Two studies evaluated the impact of drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets on plasma folate and RBC folate levels. A randomized, double-blind, active-controlled, parallel group study compared plasma folate and red blood cell (RBC) folate levels during a 24-week treatment with YAZ ® + 0.451 mg levomefolate calcium as compared to YAZ ® alone in a U.S. population. The pharmacodynamic effect on plasma folate, RBC folate, and the profile of circulating folate metabolites was assessed during 24 weeks of treatment with 0.451 mg levomefolate calcium or with 0.4 mg folic acid (equimolar dose to 0.451 mg levomefolate calcium), both in combination with 3 mg DRSP/0.03 mg EE (Yasmin ® ) followed by 20 weeks of open-label treatment with Yasmin ® only (elimination phase). [see Clinical Studies ( 14.4 ).]

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Oral Contraceptive Clinical Trial In the primary contraceptive efficacy study of YAZ® (3 mg DRSP/0.02 mg EE) of up to 1 year duration, 1,027 subjects were enrolled and completed 11,480 28-day cycles of use. The age range was 17 to 36 years. The racial demographic was: 87.8% Caucasian, 4.6% Hispanic, 4.3% Black, 1.2% Asian, and 2.1% other.

Women with a BMI greater than 35 were excluded from the trial. The pregnancy rate (Pearl Index) was 1.41 (95% CI [0.73 to 2.47]) per 100 woman-years of use based on 12 pregnancies that occurred after the onset of treatment and within 14 days after the last dose of YAZ® in women 35 years of age or younger during cycles in which no other form of contraception was used.

14.2Premenstrual Dysphoric Disorder Clinical Trials Two multicenter, double-blind, randomized, placebo-controlled studies were conducted to evaluate the effectiveness of YAZ ® in treating the symptoms of PMDD. Women aged 18 to 42 who met DSM-IV criteria for PMDD, confirmed by prospective daily ratings of their symptoms, were enrolled. Both studies measured the treatment effect of YAZ ® using the Daily Record of Severity of Problems scale, a patient-rated instrument that assesses the symptoms that constitute the DSM-IV diagnostic criteria.

The primary study was a parallel group design that included 384 evaluable reproductive-aged women with PMDD who were randomly assigned to receive YAZ ® or placebo treatment for 3 menstrual cycles. The supportive study, a crossover design, was terminated prematurely prior to achieving recruitment goals due to enrollment difficulties. A total of 64 women of reproductive age with PMDD were treated initially with YAZ ® or placebo for up to 3 cycles followed by a washout cycle and then crossed over to the alternate medication for 3 cycles.

Efficacy was assessed in both studies by the change from baseline during treatment using a scoring system based on the first 21 items of the Daily Record of Severity of Problems. Each of the 21 items was rated on a scale from 1 (not at all) to 6 (extreme); thus a maximum score of 126 was possible. In both trials, women who received YAZ ® had statistically significantly greater improvement in their Daily Record of Severity of Problems scores.

In the primary study, the average decrease (improvement) from baseline was 37.5 points in women taking YAZ ® , compared to 30.0 points in women taking placebo.

14.3Acne Clinical Trials In two multicenter, double-blind, randomized, placebo-controlled studies, 889 subjects, ages 14 to 45 years, with moderate acne received YAZ ® or placebo for six 28-day cycles. The primary efficacy endpoints were the percent change in inflammatory lesions, non-inflammatory lesions, total lesions, and the percentage of subjects with a "clear" or "almost clear" rating on the Investigator's Static Global Assessment (ISGA) scale on day 15 of cycle 6, as presented in Table 4: Table 4: Efficacy Results for Acne Trials * * Evaluated at day 15 of cycle 6, last observation carried forward for the Intent to treat population.

Study 1 Study 2 YAZ ® N = 228 Placebo N = 230 YAZ ® N = 218 Placebo N = 213 ISGA Success Rate 35 (15%) 10 (4%) 46 (21%) 19 (9%) Inflammatory Lesions Mean Baseline Count 33 33 32 32 Mean Absolute (%) Reduction 15 (48%) 11 (32%) 16 (51%) 11 (34%) Non-inflammatory Lesions Mean Baseline Count 47 47 44 44 Mean Absolute (%) Reduction 18 (39%) 10 (18%) 17 (42%) 11 (26%) Total Lesions Mean Baseline Count 80 80 76 76 Mean Absolute (%) Reduction 33 (42%) 21 (25%) 33 (46%) 22 (31%)

14.4Folate Supplementation Clinical Trials The development program for drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets consisted of two clinical trials. One study was a multicenter, randomized, double-blind, active-controlled, parallel group US study. Plasma folate and red blood cell folate levels were investigated during a 24-week treatment with YAZ ® + 0.451 mg levomefolate calcium as compa… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 201 words ▾

13 NONCLINICAL TOXICOLOGY

13.1CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY In a 24 month oral carcinogenicity study in mice dosed with 10 mg/kg/day DRSP alone or 1 + 0.01, 3 + 0.03 and 10 + 0.1 mg/kg/day of DRSP and EE, 0.1 to 2 times the exposure (AUC of DRSP) of women taking a contraceptive dose, there was an increase in carcinomas of the harderian gland in the group that received the high dose of DRSP alone. In a similar study in rats given 10 mg/kg/day DRSP alone or 0.3 + 0.003, 3 + 0.03 and 10 + 0.1 mg/kg/day DRSP and EE, 0.8 to 10 times the exposure of women taking a contraceptive dose, there was an increased incidence of benign and total (benign and malignant) adrenal gland pheochromocytomas in the group receiving the high dose of DRSP.

Mutagenesis studies for DRSP were conducted in vivo and in vitro and no evidence of mutagenic activity was observed. [See Warnings and Precautions ( 5.3 , 5.4 )]. Long-term animal studies have not been conducted to evaluate the carcinogenic potential of levomefolate. Mutagenesis studies for levomefolate were conducted in vitro and in vivo and no evidence of mutagenic activity was observed.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 198 words ▾

13.1CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY In a 24 month oral carcinogenicity study in mice dosed with 10 mg/kg/day DRSP alone or 1 + 0.01, 3 + 0.03 and 10 + 0.1 mg/kg/day of DRSP and EE, 0.1 to 2 times the exposure (AUC of DRSP) of women taking a contraceptive dose, there was an increase in carcinomas of the harderian gland in the group that received the high dose of DRSP alone. In a similar study in rats given 10 mg/kg/day DRSP alone or 0.3 + 0.003, 3 + 0.03 and 10 + 0.1 mg/kg/day DRSP and EE, 0.8 to 10 times the exposure of women taking a contraceptive dose, there was an increased incidence of benign and total (benign and malignant) adrenal gland pheochromocytomas in the group receiving the high dose of DRSP.

Mutagenesis studies for DRSP were conducted in vivo and in vitro and no evidence of mutagenic activity was observed. [See Warnings and Precautions ( 5.3 , 5.4 )]. Long-term animal studies have not been conducted to evaluate the carcinogenic potential of levomefolate. Mutagenesis studies for levomefolate were conducted in vitro and in vivo and no evidence of mutagenic activity was observed.

📚 References ~2 min read ▾

15 REFERENCES 1. US Preventive Services Task Force. Folic Acid for the Prevention of Neural Tube Defects: US Preventive Services Task Force Recommendation Statement.

Ann Intern Med 2009;150:626-631. 2. Seeger, J.D., Loughlin, J., Eng, P.M., Clifford, C.R., Cutone, J., and Walker, A.M.

(2007). Risk of thromboembolism in women taking ethinylestradiol/drospirenone and other oral contraceptives. Obstet Gynecol 110 , 587-593.

3. Dinger, J.C., Heinemann, L.A., and Kuhl-Habich, D. (2007).

The safety of a drospirenone-containing oral contraceptive: final results from the European Active Surveillance Study on oral contraceptives based on 142,475 women-years of observation. Contraception 75 , 344-354. 4.

Combined hormonal contraceptives (CHCs) and the risk of cardiovascular endpoints. Sidney, S. (primary author) http://www.fda.gov/downloads/Drugs/DrugSafety/UCM277384.pdf, accessed Oct 27, 2011.

5. Lidegaard, O., Lokkegaard, E., Svendsen, A.L., and Agger, C. (2009).

Hormonal contraception and risk of venous thromboembolism: national follow-up study. BMJ 339 , b2890. 6.

Lidegaard, O., Nielsen, L.H., Skovlund, C.W., Skjeldestad, F.E., and Lokkegaard, E. (2011). Risk of venous thromboembolism from use of oral contraceptives containing different progestogens and oestrogen doses: Danish cohort study, 2001-9.

BMJ 343 , d6423. 7. van Hylckama Vlieg, A., Helmerhorst, F.M., Vandenbroucke, J.P., Doggen, C.J., and Rosendaal, F.R. (2009).

The venous thrombotic risk of oral contraceptives, effects of oestrogen dose and progestogen type: results of the MEGA case-control study. BMJ 339 , b2921. 8.

Dinger, J., Assmann, A., Mohner, S., and Minh, T.D. (2010). Risk of venous thromboembolism and the use of dienogest- and drospirenone-containing oral contraceptives: results from a German case-control study.

J Fam Plann Reprod Health Care 36 , 123-129. 9. Jick, S.S., and Hernandez, R.K.

(2011). Risk of non-fatal venous thromboembolism in women using oral contraceptives containing drospirenone compared with women using oral contraceptives containing levonorgestrel: case-control study using United States claims data. BMJ 342 , d2151.

10. Parkin, L., Sharples, K., Hernandez, R.K., and Jick, S.S. (2011).

Risk of venous thromboembolism in users of oral contraceptives containing drospirenone or levonorgestrel: nested case-control study based on UK General Practice Research Database. BMJ 342 , d2139. 11.

Centers for Disease Control. Recommendations for the use of folic acid to reduce the number of cases of spina bifida and other neural tube defects. MMWR 1992;41(No.

RR-14).

📄 Patient Package Insert ~3 min read ▾

SPL PATIENT PACKAGE INSERT FDA Approved Patient Labeling Guide for Using Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets and Levomefolate Calcium Tablets WARNING TO WOMEN WHO SMOKE Do not use Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from birth control pills, including death from heart attack, blood clots or stroke.

This risk increases with age and the number of cigarettes you smoke. Birth control pills help to lower the chances of becoming pregnant when taken as directed. They do not protect against HIV infection (AIDS) and other sexually transmitted diseases.

What are Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets and Levomefolate Calcium Tablets? Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets are a birth control pill. It contains two female hormones, a synthetic estrogen called ethinyl estradiol and a progestin called drospirenone.

Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets also contains levomefolate calcium, which is a B vitamin. The progestin drospirenone may increase potassium. Therefore, you should not take drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets if you have kidney, liver or adrenal disease because this could cause serious heart and health problems.

Other drugs may also increase potassium. If you are currently on daily, long-term treatment for a chronic condition with any of the medications below, you should consult your healthcare provider about whether drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets are right for you, and during the first month that you take drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets, you should have a blood test to check your potassium level.

NSAIDs (ibuprofen [Motrin ® , Advil ® ], naproxen [Aleve ® and others] when taken long-term and daily for treatment of arthritis or other problems) Potassium-sparing diuretics (spironolactone and others) Potassium supplementation ACE inhibitors (Capoten ® , Vasotec ® , Zestril ® and others) Angiotensin-II receptor antagonists (Cozaar ® , Diovan ® , Avapro ® and others) Heparin Aldosterone antagonists Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets may also be taken to treat premenstrual dysphoric disorder (PMDD) if you choose to use the Pill for birth control.

Unless you have already decided to use the Pill for birth control, you should not start drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets to treat your PMDD because there are other medical therapies for PMDD that do not have the same risks as the Pill. PMDD is a mood disorder related to the menstrual cycle. PMDD significantly interferes with work or school, or with usual social activities and relationships with others.

Symptoms include markedly depressed mood, anxiety or tension, mood swings, and persistent anger or irritability. Other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD may include breast tenderness, headache, joint and muscle pain, bloating and weight gain.

These symptoms occur regularly before menstruation starts and go away within a few days following the start of the period. Diagnosis of PMDD should be made by healthcare providers. You should only use drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets for treatment of PMDD if you: Have already decided to use oral contraceptives for birth control, and… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 25 words ▾

RECENT MAJOR CHANGES Dosage and Administration ( 2.3 ) 5/2023 Contraindications, Pregnancy ( 4 ) Removed 5/2023 Warnings and Precautions ( 5.11 ) Removed 5/2023

📄 Package Label / Principal Display Panel 66 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets and Levomefolate Calcium Tablets NDC 68180-894-73 3 blister of 28's tablets each Rx Only Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets and Levomefolate Calcium Tablets NDC 68180-894-71 1 blister of 28 tablets each Rx Only Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets and Levomefolate Calcium Tablets NDC 68180-894-71 28 tablets Rx Only Image-10 Image-11 Image-12

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
5.8K
Units reimbursed last 4 qtrs
281.5K
Gross reimbursed last 4 qtrs
$489.7K
Avg / prescription
$84.56
Avg / unit
$1.7396
Latest quarter Q1 2026
1.3KRx
Medicaid pays / ea
$1.7396
gross reimbursed
vs
NADAC / ea
$1.3823
acquisition cost
=
Spread
+$0.3573
+26% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
45% FFS 55% MCO
Fee-for-service · 2,618 Rx Managed care · 3,173 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 13,020 units · 167 per 100k residents WA Idaho: 1,876 units · 95.5 per 100k residents ID Montana: 3,052 units · 270 per 100k residents MT North Dakota: 1,008 units · 129 per 100k residents ND Minnesota: no data reported MN Wisconsin: 4,732 units · 80.1 per 100k residents WI Michigan: no data reported MI New York: 28,224 units · 144 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 2,716 units · 64.2 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 12,180 units · 97.1 per 100k residents IL Indiana: 9,828 units · 143 per 100k residents IN Ohio: 21,812 units · 185 per 100k residents OH Pennsylvania: no data reported PA New Jersey: 1,288 units · 13.9 per 100k residents NJ Massachusetts: no data reported MA California: 36,450 units · 93.5 per 100k residents CA Utah: no data reported UT Colorado: 5,740 units · 97.7 per 100k residents CO Nebraska: no data reported NE Missouri: 13,160 units · 212 per 100k residents MO Kentucky: 5,656 units · 125 per 100k residents KY West Virginia: no data reported WV Virginia: 3,108 units · 35.7 per 100k residents VA Maryland: 3,780 units · 61.2 per 100k residents MD Connecticut: 728 units · 20.1 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: 2,380 units · 81.0 per 100k residents KS Arkansas: 5,740 units · 187 per 100k residents AR Tennessee: 19,208 units · 270 per 100k residents TN North Carolina: 12,376 units · 114 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: 20,216 units · 499 per 100k residents OK Louisiana: 22,260 units · 487 per 100k residents LA Mississippi: 4,032 units · 137 per 100k residents MS Alabama: 7,868 units · 154 per 100k residents AL Georgia: 728 units · 6.6 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 10,584 units · 34.7 per 100k residents TX Florida: 7,756 units · 34.3 per 100k residents FL
Units reimbursed · per 100k residents
6.6499
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Oklahoma 499 /100k
2 Louisiana 487 /100k
3 Montana 270 /100k
4 Tennessee 270 /100k
5 Missouri 212 /100k
6 Arkansas 187 /100k
7 Ohio 185 /100k
8 Washington 167 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Drospirenone, ethinyl estradiol and levomefolate calcium and levomefolate calcium — the ingredient across all brands.

Top reported reactions

Abdominal Pain Upper1
Haemorrhage1
Hyperthermia1
Malaise1
Menstruation Irregular1
Migraine1
Mood Swings1

Reporter sex

3 reports
Female · 100%
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 2 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) ✓ Available
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Lupin Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Lupin Pharmaceuticals, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 68180-0891-73 · Lupin 68180-0895-13 · Lupin →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.