Home › NDC Lookup › Ingredients › Drospirenone And Ethinyl Estradiol › 68462-0720-29
drospirenone and ethinyl estradiol Kit — NDC 68462-0720-29 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

drospirenone and ethinyl estradiol Kit — NDC 68462-720-29 (Billing 68462-0720-29)

by Glenmark Pharmaceuticals Inc., USA · 3 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK

This is a package of drospirenone and ethinyl estradiol Kit from Glenmark Pharmaceuticals Inc., USA, marketed since Aug 2015 and currently FDA-listed; retail pharmacies pay about $0.1909 per unit (NADAC). It is this product's only package size.

NDC 68462-0720-29
🏷️ FDA NDC (as labeled) 68462-720-29 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68462-720-29
Product NDC 68462-720
11-digit billing NDC 68462072029
NCPDP billing unit EA — each (per item)
RxCUI 630734, 748797, 748798
UPC 0368462720295
Application # ANDA204296
SPL Set ID 0f8f8a21-cee8-462f-98b3-6c06f2f33e0d
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-08-17
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 25990002150316
GPI class Drospirenone-Ethinyl Estradiol
GCN Seq No 060548
GCN 26737
HICL code 022026
Ingredient (HICL) Ethinyl Estradiol/Drospirenone
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 DROSPIRENONE-EE 3-0.02 MG TAB
FDB brand name Drospirenone-Ethinyl Estradiol
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 060548
  • GCN: 26737
  • GPI-14 (Medi-Span): 25990002150316
  • HICL (First Databank): 022026
  • AHFS class code: 68:12.00.00
  • RxCUI (RxNorm): 630734
Why two NDCs? The FDA registers this code as 68462-720-29 — 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 → 68462-0720-29. 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 DROSPIRENONE-EE 3-0.02 MG TAB Ingredient Ethinyl Estradiol/Drospirenone
📖 What it is MedlinePlus · NLM

Oral contraceptives (birth-control pills) containing ethinyl estradiol (an estrogen) and drospirenone (a progestin) are used to prevent pregnancy, treat certain types of acne, and to relieve the symptoms of premenstrual dysphoric disorder (symptoms that occur before the menstrual period each month). Your doctor will select the best medication for your needs. Estrogen and progestin are two female sex hormones. Combinations of estrogen and progestin work by preventing ovulation (the release of eggs from the ovaries). Oral contraceptives treat acne by decreasing the amounts of certain natural sub...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It's primarily a birth control pill, but it can do more than that. Depending on which brand you have, it may also be approved to treat moderate acne or the emotional and physical s...
  • What is this pill actually used for — is it just birth control?
  • Take one tablet every day at the same time, following the order printed on your blister pack — the order really matters. If you miss a pill, take it as soon as you remember and kee...
  • How do I take this pill and what happens if I miss one?
📖 Read our full Drospirenone / Ethinyl Estradiol 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 $0.191 $0.57 / 3 kit
Medicaid paysCMS SDUD · 12 mo $0.3384 $1.02 / 3 kit
Medicare drug plans payPart D · Q2 2026 $0.3847 $1.15 / 3 kit
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.377 $0.161
▼ Down 49% over the last 24 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
68462-0720-29 You're viewing this Main listing 3 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK 2015-08-17 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Drospirenone And Ethinyl Estradiol 00378-7300-53 Mylan 3 pouches $0.149 AB Availability likely save 22%
Drospirenone and Ethinyl Estradiol 31722-0945-31 Camber 1 kit $0.151 AB Availability likely save 21%
Zumandimine 59651-0030-28 Aurobindo 1 kit $0.151 AB Availability likely save 21%
Syeda 70700-0115-85 Xiromed, 1 kit $0.151 AB Availability likely save 21%
Drospirenone And Ethinyl Estradiol 60505-4897-08 Apotex 63 tablets $0.151 AB Availability likely save 21%
Drospirenone And Ethinyl Estradiol 68180-0868-73 Lupin 63 tablets $0.151 AB Availability likely save 21%
drospirenone and ethinyl estradiol 68462-0733-29 Glenmark 1 kit $0.151 AB Availability likely save 21%
Ocella 00555-9131-67 TEVA 1 kit $0.154 AB Discontinued save 19%
Drospirenone and ethinyl estradiol 31722-0934-31 Camber 1 kit $0.191 AB Availability likely —
Nikki 68180-0886-73 Lupin 1 kit $0.191 AB Availability likely —
Vestura 00480-4000-62 Teva 72 tablets $0.191 AB Availability likely —
drospirenone and ethinyl estradiolthis 68462-0720-29 Glenmark 1 kit $0.191 AB Availability likely —
Jasmiel 50102-0240-23 Afaxys 3 pouches $0.191 AB Availability likely —
Drospirenone and Ethinyl Estradiol 72603-0875-03 NorthStar 3 pouches $0.191 AB Availability likely —
Yasmin 50419-0402-03 Bayer 1 kit $4.397 AB Availability likely +2203%
Yaz 50419-0405-03 Bayer 1 kit $5.844 AB Availability likely +2961%
drospirenone and ethinyl estradiol 71205-0144-28 Proficient 1 kit — AB FDA listed —
Lo-Zumandimine 59651-0029-87 Aurobindo 1 pouch — AB FDA listed —
Syeda 63629-2335-01 Bryant 1 kit — AB FDA listed —
Drospirenone And Ethinyl Estradiol 79929-0019-07 Naari 21 tablets — AB FDA listed —
drospirenone and ethinyl estradiol 50090-2494-00 A-S 1 kit — AB FDA listed —
drospirenone and ethinyl estradiol 50090-2594-00 A-S 1 kit — AB FDA listed —
Drospirenone And Ethinyl Estradiol 67296-2286-03 Redpharm 63 tablets — AB FDA listed —
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

🏛️
2015
On the market since
Aug 2015
📍
2026
Currently FDA-listed
11 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.

What it looks like

Color Brown / White
ShapeRound
ImprintE6
Size6 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

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

LabelerGlenmark Pharmaceuticals Inc., USA
Application holderGLENMARK PHARMACEUTICALS LTD
FDA applicationANDA204296 (ANDA)
Labeler code68462
First marketedAug 2015
Product typeHuman Prescription Drug
Portfolio343 products on file
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 🧬 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 120 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 and ethinyl estradiol 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 and ethinyl estradiol tablets are a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, 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 women at least 14 years old only if the patient desires an oral contraceptive for birth control.

( 1.3 )

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

1.2Premenstrual Dysphoric Disorder (PMDD) Drospirenone and ethinyl estradiol 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 and ethinyl estradiol 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 and ethinyl estradiol tablets has not been evaluated for the treatment of premenstrual syndrome (PMS).

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

⏱️ 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 pack. ( 2.1 )

2.1How to Take Drospirenone and Ethinyl Estradiol 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 and ethinyl estradiol tablets must be taken exactly as directed, in the order directed on the blister pack. Single missed pills should be taken as soon as remembered.

2.2How to Start Drospirenone and Ethinyl Estradiol Tablets Instruct the patient to begin taking drospirenone and ethinyl estradiol 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 and ethinyl estradiol tablets use, instruct the patient to take one brown to reddish brown drospirenone and ethinyl estradiol tablet daily, beginning on Day 1 of her menstrual cycle. (The first day of menstruation is Day 1.) She should take one brown to reddish brown drospirenone and ethinyl estradiol tablet daily for 24 consecutive days, followed by one white to off-white inert tablet daily on Days 25 through 28.

Drospirenone and ethinyl estradiol 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 and ethinyl estradiol tablets can be taken without regard to meals. If drospirenone and ethinyl estradiol tablets are first taken later than the first day of the menstrual cycle, drospirenone and ethinyl estradiol 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 and ethinyl estradiol tablet use, instruct the patient to take one brown to reddish brown drospirenone and ethinyl estradiol tablet daily, beginning on the first Sunday after the onset of her menstrual period.

She should take one brown to reddish brown drospirenone and ethinyl estradiol tablet daily for 24 consecutive days, followed by one white to off-white inert tablet daily on Days 25 through 28. Drospirenone and ethinyl estradiol 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 and ethinyl estradiol tablets can be taken without regard to meals.

Drospirenone and ethinyl estradiol 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 and ethinyl estradiol tablets on the same day of the week that she began her first regimen, following the same schedule. She should begin taking her brown to reddish brown tablets on the next day after ingestion of the last white to off-white tablet, regardless of whether or not a menstrual period has occurred or is still in progress. Anytime a subsequent cycle of drospirenone and ethinyl estradiol tablets is started later than the day following administration of the last white to off-white tablet, the patient should use another method of contraception until she has taken a brown to reddish brown drospirenone and ethinyl estradiol tablet daily for seven consecutive days.

When switching from a different birth control… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 105 words ▾

3 DOSAGE FORMS AND STRENGTHS Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg are available in blister packs. Each blister pack (28 film-coated tablets) contains in the following order: • 24 brown to reddish brown tablets each containing 3 mg drospirenone, USP (DRSP) and 0.02 mg ethinyl estradiol, USP (EE) • 4 white to off-white inert tablets Drospirenone and Ethinyl Estradiol Tablets, USP consist of 28 film-coated, biconvex tablets in the following order ( 3 ): • 24 brown to reddish brown tablets, each containing 3 mg drospirenone, USP (DRSP) and 0.02 mg ethinyl estradiol, USP (EE) • 4 white to off-white inert tablets

⛔ Contraindications ~2 min read ▾

4 CONTRAINDICATIONS Drospirenone and ethinyl estradiol tablets are 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: o Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions ( 5.1 )] o Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions ( 5.1 )] o Have cerebrovascular disease [see Warnings and Precautions ( 5.1 )] o Have coronary artery disease [see Warnings and Precautions ( 5.1 )] o 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 )] o Have inherited or acquired hypercoagulopathies [see Warnings and Precautions ( 5.1 )] o Have uncontrolled hypertension [see Warnings and Precautions ( 5.6 )] o Have diabetes mellitus with vascular disease [see Warnings and Precautions ( 5.8 )] o 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 and ethinyl estradiol 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 and ethinyl estradiol 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 and ethinyl estradiol tablets if jaundice occurs.

( 5.4 ) • High blood pressure : Do not prescribe drospirenone and ethinyl estradiol 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 and ethinyl estradiol tablets. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia.

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

5.1Thromboembolic Disorders and Other Vascular Problems Stop drospirenone and ethinyl estradiol 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 and ethinyl estradiol 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 a All COCs available in the US during the conduct of the study b HR: 0.9 (0.5 to 1.6) EURAS (Dinger 2007) Initiators, including new users a All COCs available in Europe during the conduct of the study c HR: 0.9 (0.6 to 1.4) Levonorgestrel/EE HR: 1 (0.6 to 1.8) “FDA-funded study” (2011) New users a Other COCs available during the course of the study d HR: 1.8 (1.3 to 2.4) Levonorgestrel/0.03 mg EE HR: 1.6 (1.1 to 2.2) All users (i.e., initiation and continuing use of study combination hormonal contraception) Other COCs available during the course of the study d HR: 1.7 (1.4 to 2.1) Levonorgestrel/0.03 mg EE HR: 1.5 (1.2 to 1.8) a. “New user… [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 and acne clinical trials were: headache/migraine (6.7%), menstrual irregularities (4.7%), nausea/vomiting (4.2%), breast pain/tenderness (4.0%) and mood changes (2.2%).

( 6.1 ) • The most frequent adverse reactions (≥ 2%) in PMDD clinical trials were: 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 Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 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, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Contraception and Acne Clinical Trials The data provided reflect the experience with the use of drospirenone and ethinyl estradiol tablets in the adequate and well-controlled studies for contraception (N=1,056) and for moderate acne vulgaris (N=536).

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 drospirenone and ethinyl estradiol tablets. A second Phase 3 study was a single center, open-label, active-controlled study to evaluate the effect of 7 28-day cycles of drospirenone and ethinyl estradiol tablets 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 drospirenone and ethinyl estradiol tablets, evaluated the safety and efficacy during up to 6 cycles.

The adverse reactions seen across the 2 indications overlapped, and are reported using the frequencies from the pooled dataset. The most common adverse reactions (≥ 2% of users) were: headache/migraine (6.7%), menstrual irregularities (including vaginal hemorrhage [primarily spotting] and metrorrhagia (4.7%), nausea/vomiting (4.2%), breast pain/tenderness (4%) and mood changes (mood swings, depression, depressed mood and affect lability) (2.2%). 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 Contraception and Acne 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 drospirenone and ethinyl estradiol tablets during up to 3 cycles among 285 women aged 18–42, diagnosed with PMDD and who took at least one dose of drospirenone and ethinyl estradiol tablets. 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 due to an adverse reaction; the most frequent adverse reactions leading to discontinuation were headache/migraine (1.6%) and nausea/vomiting (1… [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 toward… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

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

8.1Pregnancy Risk Summary There is no use for contraception in pregnancy; therefore, drospirenone and ethinyl estradiol 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 DRSP/EE 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 and ethinyl estradiol 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 and ethinyl estradiol tablets on the breastfed infant. CHCs can reduce milk production in breastfeeding females. This reduction can occur at any time but is less likely to occur once breastfeeding is well-established.

When possible, advise the nursing female to use other methods of contraception until she discontinues breastfeeding [See also Dosage and Administration ( 2.2 )]. The developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for drospirenone and ethinyl estradiol tablets and any potential adverse effects on the breast-fed child from drospirenone and ethinyl estradiol 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.

8.4Pediatric Use Safety and efficacy of drospirenone and ethinyl estradiol tablets have 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.

8.5Geriatric Use Drospirenone and ethinyl estradiol tablets have not been studied in postmenopausal women and are not indicated in this population.

8.6Patients with Renal Impairment Drospirenone and ethinyl estradiol tablets are contraindicated in patients with renal impairment [see Contraindications ( 4 ) and Warnings and Precautions ( 5.2 )] . In subjects with creatinine clearance (CLcr) of 50 to 79 mL/min, serum DRSP levels were comparable to those in a control group with CLcr ≥ 80 mL/min. In subjects with CLcr of 30 to 49 mL/min, serum DRSP concentrations were on average 37% higher than those in the con… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy 169 words ▾

8.1Pregnancy Risk Summary There is no use for contraception in pregnancy; therefore, drospirenone and ethinyl estradiol 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 DRSP/EE 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 and ethinyl estradiol 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 51 words ▾

8.4Pediatric Use Safety and efficacy of drospirenone and ethinyl estradiol tablets have 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 22 words ▾

8.5Geriatric Use Drospirenone and ethinyl estradiol tablets have not been studied in postmenopausal women and are not indicated in this population.

🆘 Overdosage 53 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.

🧬 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 and ethinyl estradiol tablets is ethinyl estradiol. Contraception 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.

12.3Pharmacokinetics Absorption 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 and ethinyl estradiol tablets , which is a combination tablet 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 and ethinyl estradiol tablets. The pharmacokinetics of DRSP are dose proportional following single doses ranging from 1 to 10 mg. Following daily dosing of drospirenone and ethinyl estradiol tablets, 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 drospirenone and ethinyl estradiol tablets (see Table 3). For EE, steady-state conditions are reported during the second half of a treatment cycle. Following daily administration of drospirenone and ethinyl estradiol tablets, serum C max and AUC (0 to 24h) values of EE accumulate by a factor of about 1.5 to 2 (see Table 3).

Table 3: Pharmacokinetic Parameters of Drospirenone and Ethinyl Estradiol Tablets (DRSP 3 mg and EE 0.02 mg) DRSP Cycle / Day No. of Subjects C max a (ng/mL) T max b (h) AUC(0 to 24h) a (ng•h/mL) t 1/2 a (h) 1/1 23 38.4 (25) 1.5 (1 to 2) 268 (19) NA c 1/21 23 70.3 (15) 1.5 (1 to 2) 763 (17) 30.8 (22) EE Cycle / Day No. of Subjects C max a (pg/mL) T max b (h) AUC(0 to 24h) a (pg•h/mL) t 1/2 a (h) 1/1 23 32.8 (45) 1.5 (1 to 2) 108 (52) NA c 1/21 23 45.1 (35) 1.5 (1 to 2) 220 (57) NA c 1. geometric mean (geometric coefficient of variation) 2. median (range) 3.

NA = Not available Food Effect The rate of absorption of DRSP and EE following single administration of a formulation similar to drospirenone and ethinyl estradiol tablets was slower under fed (high fat meal) conditions with the serum C max being reduced about 40% for both components. The extent of abso… [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 116 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/ 0.02 mg are available in cartons (NDC 68462-720-29) of three blister packs (NDC 68462-720-84). Each blister contains 28 film-coated tablets in the following order: • 24 round, brown to reddish brown film-coated tablets, each containing 3 mg drospirenone, USP and 0.02 mg ethinyl estradiol, USP debossed with “E3” on one side and unscored on the other., • 4 round, white to off-white film-coated inert tablets, debossed with “E6” on one side and unscored on the other.

16.2Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

📋 Description 185 words ▾

11 DESCRIPTION Drospirenone and Ethinyl Estradiol Tablets, USP provide an oral contraceptive regimen consisting of 24 brown to reddish brown active film-coated tablets each containing 3 mg of drospirenone, USP and 0.02 mg of ethinyl estradiol, USP and 4 white to off-white inert film-coated tablets. The inactive ingredients in the brown to reddish brown tablets are corn starch, crospovidone, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, povidone, talc, titanium dioxide. The white to off-white inert film-coated tablets contain anhydrous lactose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol, polysorbate 80, titanium dioxide.

Drospirenone, USP (6 R ,7 R ,8 R ,9 S ,10 R ,13S,14 S ,15 S ,16 S ,17 S )-1,3’,4’,6,6a,7,8,9,10,11,12,13,14,15,15a,16-hexadecahydro-10,13-dimethylspiro-[17 H -dicyclopropa[6,7:15,16]cyclopenta[a]phenanthrene-17,2’(5’H)-furan]-3,5’(2H)-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, USP (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 296.4 and a molecular formula of C 20 H 24 O 2 .

The structural formulas are as follows: Drospirenone, USP Ethinyl Estradiol, USP drospirenone.jpg eestructure

💬 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 and ethinyl estradiol tablets do not protect against HIV-infection (AIDS) and other sexually transmitted diseases. • Counsel patients on Warnings and Precautions associated with COCs. • Counsel patients that drospirenone and ethinyl estradiol 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 and ethinyl estradiol 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 and ethinyl estradiol tablets are not indicated during pregnancy.

If pregnancy occurs during treatment with drospirenone and ethinyl estradiol tablets, instruct the patient to stop further 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 brown to reddish brown 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. Trademarks are the property of their respective owners. Distributed by: Glenmark Pharmaceuticals Inc., USA Elmwood Park, NJ 07407 Questions?

1 (888) 721-7115 www.glenmarkpharma-us.com June 2025 logo

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Absorption 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 and ethinyl estradiol tablets , which is a combination tablet 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 and ethinyl estradiol tablets. The pharmacokinetics of DRSP are dose proportional following single doses ranging from 1 to 10 mg. Following daily dosing of drospirenone and ethinyl estradiol tablets, 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 drospirenone and ethinyl estradiol tablets (see Table 3). For EE, steady-state conditions are reported during the second half of a treatment cycle. Following daily administration of drospirenone and ethinyl estradiol tablets, serum C max and AUC (0 to 24h) values of EE accumulate by a factor of about 1.5 to 2 (see Table 3).

Table 3: Pharmacokinetic Parameters of Drospirenone and Ethinyl Estradiol Tablets (DRSP 3 mg and EE 0.02 mg) DRSP Cycle / Day No. of Subjects C max a (ng/mL) T max b (h) AUC(0 to 24h) a (ng•h/mL) t 1/2 a (h) 1/1 23 38.4 (25) 1.5 (1 to 2) 268 (19) NA c 1/21 23 70.3 (15) 1.5 (1 to 2) 763 (17) 30.8 (22) EE Cycle / Day No. of Subjects C max a (pg/mL) T max b (h) AUC(0 to 24h) a (pg•h/mL) t 1/2 a (h) 1/1 23 32.8 (45) 1.5 (1 to 2) 108 (52) NA c 1/21 23 45.1 (35) 1.5 (1 to 2) 220 (57) NA c 1. geometric mean (geometric coefficient of variation) 2. median (range) 3.

NA = Not available Food Effect The rate of absorption of DRSP and EE following single administration of a formulation similar to drospirenone and ethinyl estradiol 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.

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 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 and CBG. EE induced effects on SHBG and CBG were not affected by variation of the DRSP dosage in the range of 2 to 3 mg.

Metabolism The two main metabolites of DRSP found in human plasma were identified to be the acid form of DRSP generated by opening of the lactone ring and the 4,5-dihydrodrospirenone-3-sulfate, formed by reduction and subsequent sulfation. These metabolites were shown not to be pharmacologically active. Drospirenone is also subject to oxidative metabolism catalyzed by CYP3A4.

EE has been reported to be subject to significant gut and hepatic first-pass metabolism. Metabolism of EE and its oxidative metabolites occur primarily by conjugation with glucuronide or sulfate. CYP3A4 in the liver is responsible for the 2-hydroxylation which is the major oxidative reaction.

The 2-hydroxy metabolite is further transformed by methylation and glucuronidation prior to urinary and fecal excretion. Excretion DRSP serum concentrations are characterized by a terminal disposition phase half-life of approximately 30 hours after both single and multiple dose regimens. Excretion of DRSP was nearly complete after ten days and amounts excreted were slightly higher in feces compared to u… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics ~1 min read ▾

12.2Pharmacodynamics Drospirenone is a spironolactone analogue with anti-mineralocorticoid and antiandrogenic activity . The estrogen in drospirenone and ethinyl estradiol tablets is ethinyl estradiol. Contraception 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.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Oral Contraceptive Clinical Trial In the primary contraceptive efficacy study of drospirenone and ethinyl estradiol tablets (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, 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 drospirenone and ethinyl estradiol tablets 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 drospirenone and ethinyl estradiol tablets in treating the symptoms of PMDD. Women aged 18–42 who met DSM-IV criteria for PMDD, confirmed by prospective daily ratings of their symptoms, were enrolled. Both studies measured the treatment effect of drospirenone and ethinyl estradiol tablets 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 drospirenone and ethinyl estradiol tablets 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 drospirenone and ethinyl estradiol tablets 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 drospirenone and ethinyl estradiol tablets 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 drospirenone and ethinyl estradiol tablets, 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 drospirenone and ethinyl estradiol tablets 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* Study 1 Study 2 DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS N=228 Placebo N=230 DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS 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%) * Evaluated at day 15 of cycle 6, last observation carried forward for the Intent to treat population

🧪 Nonclinical Toxicology 166 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 )].

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 163 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 )].

📚 References ~1 min read ▾

15 REFERENCES 1. 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. 2.

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. 3. 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. 4.

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. 5. 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.

6. 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. 7. 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.

8. 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. 9.

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.

📄 Patient Package Insert ~3 min read ▾

FDA Approved Patient Labeling Guide for Using Drospirenone and Ethinyl Estradiol Tablets WARNING TO WOMEN WHO SMOKE Do not use drospirenone and ethinyl estradiol 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 and Ethinyl Estradiol Tablets?

Drospirenone and ethinyl estradiol tablets are birth control pills. It contains two female hormones, a synthetic estrogen called ethinyl estradiol and a progestin called drospirenone. The progestin drospirenone may increase potassium.

Therefore, you should not take drospirenone and ethinyl estradiol 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 and ethinyl estradiol tablets are right for you, and during the first month that you take drospirenone and ethinyl estradiol 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 and ethinyl estradiol 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 and ethinyl estradiol 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 and ethinyl estradiol tablets for treatment of PMDD if you: • Have already decided to use oral contraceptives for birth control, and • Have been diagnosed with PMDD by your healthcare provider.

Drospirenone and ethinyl estradiol tablets have not been shown to be effective for the treatment of premenstrual syndrome (PMS), a less serious set of symptoms occurring before menstruation. If you or your healthcare provider believe you have PMS, you should take drospirenone and ethinyl estradiol tablets only if you want to prevent pregnancy; and not for the treatment of PMS. Drospirenone and ethinyl estradiol tablets may also be taken to treat moderate acne if all of the following are true: • Your healthcare provider says it is safe for you to use drospirenone and ethinyl estradiol tablets. • You are at least 14 years old. • You have started having menstrual periods. • Y… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 22 words ▾

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 15 words ▾

Principle Display Panel NDC 68462-720-29 Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg carton

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
109.9K
Units reimbursed last 4 qtrs
6.2M
Gross reimbursed last 4 qtrs
$2.08M
Avg / prescription
$18.96
Avg / unit
$0.3384
Latest quarter Q1 2026
27.5KRx
Medicaid pays / ea
$0.3384
gross reimbursed
vs
NADAC / ea
$0.1909
acquisition cost
=
Spread
+$0.1475
+77% 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 ⓘ
37% FFS 63% MCO
Fee-for-service · 40,442 Rx Managed care · 69,438 Rx
State Medicaid map
Alaska: 33,796 units · 4,611 per 100k residents AK Maine: no data reported ME Washington: 298,676 units · 3,823 per 100k residents WA Idaho: 70,840 units · 3,607 per 100k residents ID Montana: 52,668 units · 4,653 per 100k residents MT North Dakota: 10,192 units · 1,302 per 100k residents ND Minnesota: 281,848 units · 4,913 per 100k residents MN Wisconsin: 279,244 units · 4,725 per 100k residents WI Michigan: 298,122 units · 2,970 per 100k residents MI New York: 438,258 units · 2,239 per 100k residents NY Vermont: 33,012 units · 5,102 per 100k residents VT New Hampshire: 34,300 units · 2,447 per 100k residents NH Oregon: 275,600 units · 6,511 per 100k residents OR Nevada: 56,420 units · 1,766 per 100k residents NV Wyoming: 12,544 units · 2,148 per 100k residents WY South Dakota: 7,168 units · 780 per 100k residents SD Iowa: 76,496 units · 2,385 per 100k residents IA Illinois: 423,474 units · 3,375 per 100k residents IL Indiana: 50,708 units · 739 per 100k residents IN Ohio: 185,864 units · 1,577 per 100k residents OH Pennsylvania: 151,480 units · 1,169 per 100k residents PA New Jersey: 56,952 units · 613 per 100k residents NJ Massachusetts: 86,632 units · 1,237 per 100k residents MA California: 284,998 units · 731 per 100k residents CA Utah: 45,374 units · 1,328 per 100k residents UT Colorado: 203,028 units · 3,454 per 100k residents CO Nebraska: 64,848 units · 3,278 per 100k residents NE Missouri: 168,448 units · 2,719 per 100k residents MO Kentucky: 145,572 units · 3,216 per 100k residents KY West Virginia: 50,876 units · 2,874 per 100k residents WV Virginia: 92,316 units · 1,059 per 100k residents VA Maryland: 72,522 units · 1,173 per 100k residents MD Connecticut: 98,616 units · 2,726 per 100k residents CT Rhode Island: 4,592 units · 419 per 100k residents RI Arizona: 153,636 units · 2,068 per 100k residents AZ New Mexico: 138,824 units · 6,567 per 100k residents NM Kansas: 22,260 units · 757 per 100k residents KS Arkansas: 44,716 units · 1,458 per 100k residents AR Tennessee: 226,016 units · 3,172 per 100k residents TN North Carolina: 255,696 units · 2,360 per 100k residents NC South Carolina: 37,072 units · 690 per 100k residents SC Delaware: 42,168 units · 4,090 per 100k residents DE Oklahoma: 88,536 units · 2,184 per 100k residents OK Louisiana: 202,580 units · 4,429 per 100k residents LA Mississippi: 23,498 units · 799 per 100k residents MS Alabama: 74,816 units · 1,465 per 100k residents AL Georgia: 48,916 units · 444 per 100k residents GA D.C.: no data reported DC Hawaii: 52,808 units · 3,680 per 100k residents HI Texas: 126,786 units · 416 per 100k residents TX Florida: 172,454 units · 763 per 100k residents FL
Units reimbursed · per 100k residents
4166,567
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 New Mexico 6,567 /100k
2 Oregon 6,511 /100k
3 Vermont 5,102 /100k
4 Minnesota 4,913 /100k
5 Wisconsin 4,725 /100k
6 Montana 4,653 /100k
7 Alaska 4,611 /100k
8 Louisiana 4,429 /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.

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 ✓ Available
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 Glenmark Pharmaceuticals Inc., USA. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Glenmark Pharmaceuticals Inc., USA 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.
← 68462-0714-05 · Glenmark 68462-0721-01 · Glenmark →
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.