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OCELLA drospirenone and ethinyl estradiol Kit — NDC 0555-9131-67 (Billing 00555-9131-67)

by TEVA PHARMACEUTICALS USA, INC. · 3 BLISTER PACK in 1 PACKAGE / 1 KIT in 1 BLISTER PACK

This is a package of OCELLA drospirenone and ethinyl estradiol Kit from TEVA PHARMACEUTICALS USA, INC., no longer marketed (first marketed Jun 2001), no longer in the FDA NDC Directory, this package's marketing ended Jun 2026; retail pharmacies pay about $0.1538 per unit (NADAC). It is this product's only package size.

NDC 00555-9131-67
🏷️ FDA NDC (as labeled) 0555-9131-67 billing pads the labeler segment with a zero
Rx only Brand Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 2, 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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Jun 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0555-9131-67
Product NDC 0555-9131
11-digit billing NDC 00555913167
NCPDP billing unit EA — each (per item)
RxCUI 284207, 748797, 748800, 801185
Application # NDA021098
SPL Set ID 0d729f4d-2fa3-47f6-8a1f-d8cfea4cff37
DEA schedule Non-controlled
Marketing category NDA AUTHORIZED GENERIC
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Jun 2026)
Marketing start 2001-06-11
Marketing end 2026-06-30
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 25990002150320
GPI class Ocella
GCN Seq No 047787
GCN 13083
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 OCELLA 3 MG-0.03 MG TABLET
FDB brand name Ocella
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 047787
  • GCN: 13083
  • GPI-14 (Medi-Span): 25990002150320
  • HICL (First Databank): 022026
  • AHFS class code: 68:12.00.00
  • RxCUI (RxNorm): 284207
Why two NDCs? The FDA registers this code as 0555-9131-67 — a 4-4-2 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 labeler segment → 00555-9131-67. 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 OCELLA 3 MG-0.03 MG TABLET 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 ↗

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 $0.154 $0.46 / 3 kit
Medicaid paysCMS SDUD · 12 mo $0.7757 $2.33 / 3 kit
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Feb 2024 Jun 2026 $0.277 $0.154
▼ Down 40% over the last 22 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
00555-9131-67 You're viewing this Main listing 3 BLISTER PACK in 1 PACKAGE / 1 KIT in 1 BLISTER PACK 2001-06-11 Jun 30, 2026 Discontinued by firm

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Drospirenone And Ethinyl Estradiol 00378-7300-53 Mylan 3 pouches $0.149 AB Availability likely save 3%
Drospirenone and Ethinyl Estradiol 31722-0945-31 Camber 1 kit $0.151 AB Availability likely save 2%
Zumandimine 59651-0030-28 Aurobindo 1 kit $0.151 AB Availability likely save 2%
Syeda 70700-0115-85 Xiromed, 1 kit $0.151 AB Availability likely save 2%
Drospirenone And Ethinyl Estradiol 60505-4897-08 Apotex 63 tablets $0.151 AB Availability likely save 2%
Drospirenone And Ethinyl Estradiol 68180-0868-73 Lupin 63 tablets $0.151 AB Availability likely save 2%
drospirenone and ethinyl estradiol 68462-0733-29 Glenmark 1 kit $0.151 AB Availability likely save 2%
Ocellathis 00555-9131-67 TEVA 1 kit $0.154 AB Discontinued —
Drospirenone and ethinyl estradiol 31722-0934-31 Camber 1 kit $0.191 AB Availability likely +24%
Nikki 68180-0886-73 Lupin 1 kit $0.191 AB Availability likely +24%
Vestura 00480-4000-62 Teva 72 tablets $0.191 AB Availability likely +24%
drospirenone and ethinyl estradiol 68462-0720-29 Glenmark 1 kit $0.191 AB Availability likely +24%
Jasmiel 50102-0240-23 Afaxys 3 pouches $0.191 AB Availability likely +24%
Drospirenone and Ethinyl Estradiol 72603-0875-03 NorthStar 3 pouches $0.191 AB Availability likely +24%
Yasmin 50419-0402-03 Bayer 1 kit $4.397 AB Availability likely +2759%
Yaz 50419-0405-03 Bayer 1 kit $5.844 AB Availability likely +3699%
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 an authorized generic — the brand-name product marketed without its brand name. 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

🏛️
2001
On the market since
Jun 2001
📍
2026
Currently FDA-listed
25 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
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

LabelerTEVA PHARMACEUTICALS USA, INC.
Application holderBAYER HEALTHCARE PHARMACEUTICALS INC
FDA applicationNDA021098 (NDA AUTHORIZED GENERIC)
Labeler code00555
First marketedJun 2001
Product typeHuman Prescription Drug
Portfolio504 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 📄 Patient Package Insert 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 116 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 OCELLA. ( 4 ) • Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. ( 4 )

🎯 Indications and Usage 44 words ▾

1 INDICATIONS AND USAGE OCELLA® is indicated for use by females of reproductive potential to prevent pregnancy. OCELLA is a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 )

⏱️ 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 OCELLA 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 effectiveness, OCELLA must be taken as directed, in the order directed on the blister pack. Single missed pills should be taken as soon as remembered.

2.2How to Start OCELLA Instruct the patient to begin taking OCELLA 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 OCELLA use, instruct the patient to take one yellow OCELLA daily, beginning on Day 1 of her menstrual cycle. (The first day of menstruation is Day 1.) She should take one yellow OCELLA daily for 21 consecutive days, followed by one white tablet daily on Days 22 through 28.

OCELLA 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. OCELLA can be taken without regard to meals. If OCELLA is first taken later than the first day of the menstrual cycle, OCELLA 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 OCELLA use, instruct the patient to take one yellow OCELLA daily, beginning on the first Sunday after the onset of her menstrual period.

She should take one yellow OCELLA daily for 21 consecutive days, followed by one white tablet daily on Days 22 through 28. OCELLA 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. OCELLA can be taken without regard to meals.

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

When switching from a different birth control pill When switching from another birth control pill, OCELLA should be started on the same day that a new pack of the previous oral contraceptive would have been started. When switching from a method other than a birth control pill When switching from a transdermal patch or vaginal ring, OCELLA should be started when the next application would have been due. When switching from an injection, OCELLA should be started when the next dose would have been due.

When switching from an intrauterine contraceptive or an implant, OCELLA should be started on the day of removal. Withdrawal bleeding usually occurs within 3 days following the last yellow tablet. If spotting or breakthrough bleeding occurs while taking OCELLA, instruct the patient to continue taking OCELLA by the regimen described above.

Counsel her that this type of bleeding is usually transient and without significance; however… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 105 words ▾

3 DOSAGE FORMS AND STRENGTHS OCELLA (drospirenone/ethinyl estradiol) tablets are available in blister packs. Each blister pack contains 28 film-coated, round, bi-convex tablets in the following order: • 21 yellow tablets each containing 3 mg drospirenone (DRSP) and 0.03 mg ethinyl estradiol (EE) embossed with a “DO” in a regular hexagon on one side • 7 inert white tablets embossed with a “DP” in a regular hexagon on one side OCELLA consists of 28 film-coated, biconvex tablets in the following order ( 3 ): • 21 yellow tablets, each containing 3 mg drospirenone (DRSP) and 0.03 mg ethinyl estradiol (EE) • 7 inert white tablets

⛔ Contraindications ~2 min read ▾

4 CONTRAINDICATIONS OCELLA 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 tumor (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 ( 7.2 )]. • 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 OCELLA 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 OCELLA 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 OCELLA if jaundice occurs.

( 5.4 ) • High blood pressure : Do not prescribe OCELLA for women with uncontrolled hypertension or hypertension with vascular disease. ( 5.6 ) • Carbohydrate and lipid metabolic effects : Monitor prediabetic and diabetic women taking OCELLA. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia.

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

5.1Thromboembolic Disorders and Other Vascular Problems Stop OCELLA if an arterial or venous thrombotic (VTE) event occurs. Based on presently available information on OCELLA, 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 OCELLA 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 3 mg of DRSP and 0.03 mg of EE) 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: norgestimate, norethindrone, levonorgestrel, desogestrel, norgestrel, medroxyprogesterone, or ethynodiol diacetate HR: 0.9 (0.5-1.6) EURAS (Dinger 2007) Initiators, including new users All COCs available in Europe during the conduct of the study Includes low-dose COCs containing the following progestins: levonorgestrel, desogestrel, dienogest, chlormadinone acetate, gestodene, cyproterone acetate, norgestimate, or norethindrone HR: 0.9 (0.6-1.4) Levonorgestrel/EE HR: 1.0 (0.6-1.8) “FDA-funded study” (2011) New users Other COCs available during the course of the study Includes low-dose COCs containing the following progestins: norgestimate, norethindrone, or levonorgestrel HR: 1.8 (1.3-2.4) Levonorgestrel/0.03 mg EE HR: 1.6 (1.1-2.2) All users (i.e., initiation and continuing u… [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%) are premenstrual syndrome (13.2%), headache /migraine (10.7%), breast pain/tenderness/discomfort (8.3%), nausea/vomiting (4.5%), abdominal pain/tenderness/discomfort (2.3%), mood changes (2.3%).

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact TEVA USA at 1-888-838-2872 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. The data provided reflect the experience with the use of OCELLA (3 mg DRSP/0.03 mg EE) in the adequate and well-controlled studies for contraception (N=2,837). The US pivotal clinical study (N=326) was a multicenter, open-label trial in healthy women aged 18 -35 who were treated for up to 13 cycles.

The second pivotal study (N=442)was a multicenter, randomized, open-label comparative European study of OCELLA vs. 0.150 mg desogestrel/0.03 mg EE conducted in healthy women aged 17-40 who were treated for up to 26 cycles. The most common adverse reactions (≥ 2% of users) were: premenstrual syndrome (13.2%), headache/migraine (10.7%), breast pain/tenderness/discomfort (8.3%), nausea/vomiting (4.5%) abdominal pain/discomfort/tenderness (2.3%) and mood changes (depression, depressed mood, irritability, mood swings, mood altered and affect lability (2.3%).

Adverse Reactions (≥ 1%) Leading to Study Discontinuation : Of 2,837 women, 6.7% discontinued from the clinical trials due to an adverse reaction; the most frequent adverse reaction leading to discontinuation was headache/migraine (1.5%). Serious Adverse Reactions : Depression, pulmonary embolism, toxic skin eruption, and uterine leiomyoma.

6.2Postmarketing Experience Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 - 1.12 (Figure 3). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 3). One of these studies reported no association between breast cancer risk and COC use.

The other two studies found an increased relative risk of 1.19 - 1.33 with current or recent use. Both of these studies found an increased risk of breast cancer with current use of longer duration, with relative risks ranging from 1.03 with less than one year of COC use to approximately 1.4 with more than 8-10 years of COC use. Figure 3 Relative Studies of Risk of Breast Cancer with Combined Oral Contraceptives RR = relative risk; OR = odds ratio; HR = hazard ratio. “ever COC” are females with current or past COC use; “never COC use” are females that never used COCs.

The following adverse reactions have been identified during post-approval use of OCELLA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions, including fatalities, are grouped into System Organ Classes and ordered by frequency.

Vascular disorders: Venous and arterial thromboembolic events (including pulmonary emboli, deep vein thrombosis, intracardiac thrombosis, intracranial venous sinus thrombosis, sagittal sinus thrombosis, retinal vein occlusion, myocardial infarction and stroke), hypertension Hepatobiliary disorders: Gallbladder disease Immune system disorders: Hypersensitivity Met… [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 towar… [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, OCELLA 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 OCELLA 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 OCELLA 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 )]. The developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for Ocella and any potential adverse effects on the breast-fed child from OCELLAor 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 C max of 13.5 ng/mL, while the mean C max 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 OCELLA 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.

8.5Geriatric Use OCELLA has not been studied in postmenopausal women and is not indicated in this population.

8.6Patients with Renal Impairment OCELLA is contraindicated in patients with renal impairment [see Contraindications ( 4 ) and Warnings and Precautions ( 5.2 )] . In subjects with creatinine clearance (CLcr) of 50–79 mL/min, serum DRSP concentrations were comparable to those in a control group with CLcr ≥ 80 mL/min. In subjects with CLcr of 30–49 mL/min, serum DRSP concentrations were on average 37% higher than those in the control group.

In addition, there is a potential to develop hyperkalemia in subjects with renal impairment whose serum potassium is in the upper reference range, and who are concomitantly using potassium sparing drugs [see Clinical Pharmacology ( 12.3 )] .

8.7Pat… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy 162 words ▾

8.1Pregnancy Risk Summary There is no use for contraception in pregnancy; therefore, OCELLA 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 OCELLA 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 47 words ▾

8.4Pediatric Use Safety and efficacy of OCELLA 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 18 words ▾

8.5Geriatric Use OCELLA has not been studied in postmenopausal women and is 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 activity. The estrogen in OCELLA is ethinyl estradiol (EE). No specific pharmacodynamic studies were conducted with OCELLA.

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 OCELLA, which is a combination tablet of DRSP and EE, has not been evaluated.

Serum concentrations of DRSP and EE reached peak levels within 1-2 hours after administration of OCELLA. The pharmacokinetics of DRSP are dose proportional following single doses ranging from 1-10 mg. Following daily dosing of OCELLA, steady state DRSP concentrations were observed after 8 days.

There was about 2 to 3 fold accumulation in serum C max and AUC (0-24h) values of DRSP following multiple dose administration of OCELLA (see Table 3). For EE, steady-state conditions are reported during the second half of a treatment cycle. Following daily administration of OCELLA serum C max and AUC (0-24h) values of EE accumulate by a factor of about 1.5 to 2 (see Table 3).

Table 3: Mean Pharmacokinetic Parameters of Yasmin (DRSP 3 mg and EE 0.03 mg) DRSP Mean (%CV) Values Cycle / Day No. of Subjects C max (ng/mL) T max (h) AUC(0-24h) (ng•h/mL) t 1/2 (h) 1/1 12 36.9 (13) 1.7 (47) 288 (25) NA NA-Not available 1/21 12 87.5 (59) 1.7 (20) 827 (23) 30.9 (44) 6/21 12 84.2 (19) 1.8 (19) 930 (19) 32.5 (38) 9/21 12 81.3 (19) 1.6 (38) 957 (23) 31.4 (39) 13/21 12 78.7 (18) 1.6 (26) 968 (24) 31.1 (36) EE Mean (%CV) Values Cycle / Day No. of Subjects C max (pg/mL) T max (h) AUC(0-24h) (pg•h/mL) t 1/2 (h) 1/1 11 53.5 (43) 1.9 (45) 280 (87) NA 1/21 11 92.1 (35) 1.5 (40) 461 (94) NA 6/21 11 99.1 (45) 1.5 (47) 346 (74) NA 9/21 11 87 (43) 1.5 (42) 485 (92) NA 13/21 10 90.5 (45) 1.6 (38) 469 (83) NA Food Effect The rate of absorption of DRSP and EE following single administration of a formulation similar to OCELLA was slower under fed (high fat meal) conditions with the serum Cmax 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 4–5 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 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 the 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.

Exc… [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 114 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied OCELLA (drospirenone/ethinyl estradiol) tablets are available in packages of three blister packs (NDC 0555-9131-67). The film-coated tablets are rounded with biconvex faces, one side is embossed with a regular hexagon shape with DO or DP. Each blister pack contains 28 film-coated tablets in the following order: • 21 round, biconvex, yellow, film-coated tablets with embossed “DO” in a regular hexagon on one side each containing 3 mg drospirenone and 0.03 mg ethinyl estradiol • 7 round, biconvex, white, film-coated tablets with embossed “DP” in a regular hexagon on one side

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

📋 Description 169 words ▾

11 DESCRIPTION OCELLA (drospirenone/ethinyl estradiol) tablets provide an oral contraceptive regimen consisting of 28 film-coated tablets that contain the ingredients specified for each tablet below: • 21 yellow tablets each containing 3 mg DRSP and 0.03 mg EE • 7 inert white tablets The inactive ingredients in the yellow tablets are lactose monohydrate NF, corn starch NF, pregelatinized starch NF, povidone 25000 NF, magnesium stearate NF, hypromellose USP, macrogol 6000 NF, titanium dioxide USP, talc USP, and ferric oxide pigment, yellow NF.

The white inert film-coated tablets contain lactose monohydrate NF, microcrystalline cellulose NF, magnesium stearate NF, hypromellose USP, talc USP, and titanium dioxide USP. Drospirenone (6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-1,3',4',6,6a,7,8,9,10,11,12,13, 14,15,15a,16-hexadecahydro-10,13-dimethylspiro-[17H-dicyclopropa-[6,7:15,16] cyclopenta[a]phenanthrene-17,2'(5H)-furan]-3,5'(2H)-dione) is a synthetic progestational compound and has a molecular weight of 366.5 and a molecular formula of C 24 H 30 O 3 . Ethinyl estradiol (19-nor-17α-pregna 1,3,5(10)-triene-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: Structural Formulas

💬 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 OCELLA does not protect against HIV infection (AIDS) and other sexually transmitted diseases. • Counsel patients on Warnings and Precautions associated with COCs. • Counsel patients that OCELLA 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 OCELLA 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 OCELLA is not indicated during pregnancy.

If pregnancy occurs during treatment with OCELLA, 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 yellow 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.

🧬 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 OCELLA, which is a combination tablet of DRSP and EE, has not been evaluated.

Serum concentrations of DRSP and EE reached peak levels within 1-2 hours after administration of OCELLA. The pharmacokinetics of DRSP are dose proportional following single doses ranging from 1-10 mg. Following daily dosing of OCELLA, steady state DRSP concentrations were observed after 8 days.

There was about 2 to 3 fold accumulation in serum C max and AUC (0-24h) values of DRSP following multiple dose administration of OCELLA (see Table 3). For EE, steady-state conditions are reported during the second half of a treatment cycle. Following daily administration of OCELLA serum C max and AUC (0-24h) values of EE accumulate by a factor of about 1.5 to 2 (see Table 3).

Table 3: Mean Pharmacokinetic Parameters of Yasmin (DRSP 3 mg and EE 0.03 mg) DRSP Mean (%CV) Values Cycle / Day No. of Subjects C max (ng/mL) T max (h) AUC(0-24h) (ng•h/mL) t 1/2 (h) 1/1 12 36.9 (13) 1.7 (47) 288 (25) NA NA-Not available 1/21 12 87.5 (59) 1.7 (20) 827 (23) 30.9 (44) 6/21 12 84.2 (19) 1.8 (19) 930 (19) 32.5 (38) 9/21 12 81.3 (19) 1.6 (38) 957 (23) 31.4 (39) 13/21 12 78.7 (18) 1.6 (26) 968 (24) 31.1 (36) EE Mean (%CV) Values Cycle / Day No. of Subjects C max (pg/mL) T max (h) AUC(0-24h) (pg•h/mL) t 1/2 (h) 1/1 11 53.5 (43) 1.9 (45) 280 (87) NA 1/21 11 92.1 (35) 1.5 (40) 461 (94) NA 6/21 11 99.1 (45) 1.5 (47) 346 (74) NA 9/21 11 87 (43) 1.5 (42) 485 (92) NA 13/21 10 90.5 (45) 1.6 (38) 469 (83) NA Food Effect The rate of absorption of DRSP and EE following single administration of a formulation similar to OCELLA was slower under fed (high fat meal) conditions with the serum Cmax 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 4–5 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 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 the 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 urine. DRSP was extensively metabolized and only trace amounts… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 26 words ▾

12.2Pharmacodynamics Drospirenone is a spironolactone analogue with anti-mineralocorticoid activity. The estrogen in OCELLA is ethinyl estradiol (EE). No specific pharmacodynamic studies were conducted with OCELLA.

🔬 Clinical Studies 82 words ▾

14 CLINICAL STUDIES In the clinical efficacy studies of up to 2 years duration, 2,629 subjects completed 33,160 cycles of use without any other contraception. The mean age of the subjects was 25.5 ± 4.7 years. The age range was 16 to 37 years.

The racial demographic was: 83% Caucasian, 1% Hispanic, 1% Black, <1% Asian, <1% other, <1% missing data, 14% not inquired and <1% unspecified. Pregnancy rates in the clinical trials were less than one per 100 woman-years of use.

🧪 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 )].

📄 Patient Package Insert ~3 min read ▾

FDA Approved Patient Labeling Guide for Using OCELLA WARNING TO WOMEN WHO SMOKE Do not use OCELLA 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 Is OCELLA ?

OCELLA is a birth control pill. 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 OCELLA 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 OCELLA is right for you, and during the first month that you take OCELLA, 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 How Well Does OCELLA Work?

Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The better you follow the directions, the less chance you have of getting pregnant. Based on the results of two clinical studies, about 1 woman out of 100 women may get pregnant during the first year they use OCELLA.

The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart.

The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant. How Do I Take OCELLA? 1.

Be sure to read these directions before you start taking your pills or anytime you are not sure what to do. 2. The right way to take the pill is to take one pill every day at the same time in the order directed on the package.

Preferably, take the pill after the evening meal or at bedtime, with some liquid, as needed. OCELLA can be taken without regard to meals. If you miss pills you could get pregnant.

This includes starting the pack late. The more pills you miss, the more likely you are to get pregnant. See "WHAT TO DO IF YOU MISS PILLS” below.

3. Many women have spotting or light bleeding at unexpected times, or may feel sick to their stomach during the first 1-3 packs of pills. If you do have spotting or light bleeding or feel sick to your stomach, do not stop taking the pill.

The problem will usually go away. If it does not go away, check with your healthcare provider. 4.

Missing pills can also cause spotting or light bleeding, even when you make up these missed pills. On the days you take two pills, to make up for missed pills, you could also feel a little sick to your stomach. 5.

If you have vomiting (within 3 to 4 hours after you take your pill), you should follow the instructions for "WHAT TO DO IF YOU MISS PILLS." If you have diarrhea or if you take certain medicines, including some antibiotics and some herbal products such as St. John's Wort, your pills may not work as well. Use a back-up method (such as condoms and spermicides) until you check with your healthcare provider.

6. If you have tr… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 18 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 87 words ▾

NDC 0555-9131-79 1 Unit OCELLA™ (drospirenone and ethinyl estradiol tablets) 3 mg/0.03 mg This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases. Store at 25°C with excursions permitted between15–30°C. [See USP Controlled Room Temperature].

To the Dispenser: This unit contains two pieces of information intended for the patient, which are combined in a single booklet. This informational piece is to be provided to the patient with each prescription. Rx only serialized 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
1.1K
Units reimbursed last 4 qtrs
57.1K
Gross reimbursed last 4 qtrs
$44.3K
Avg / prescription
$41.82
Avg / unit
$0.7757
Latest quarter Q1 2026
0Rx
Medicaid pays / ea
$0.7757
gross reimbursed
vs
NADAC / ea
$0.1538
acquisition cost
=
Spread
+$0.6219
+404% 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 ⓘ
53% FFS 47% MCO
Fee-for-service · 564 Rx Managed care · 495 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 3,892 units · 49.8 per 100k residents WA Idaho: no data reported ID Montana: 700 units · 61.8 per 100k residents MT North Dakota: no data reported ND Minnesota: 3,108 units · 54.2 per 100k residents MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 18,368 units · 93.9 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 644 units · 20.1 per 100k residents IA Illinois: 3,192 units · 25.4 per 100k residents IL Indiana: no data reported IN Ohio: 588 units · 5.0 per 100k residents OH Pennsylvania: 2,772 units · 21.4 per 100k residents PA New Jersey: 560 units · 6.0 per 100k residents NJ Massachusetts: 1,008 units · 14.4 per 100k residents MA California: 8,153 units · 20.9 per 100k residents CA Utah: 448 units · 13.1 per 100k residents UT Colorado: 2,309 units · 39.3 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 756 units · 16.7 per 100k residents KY West Virginia: 420 units · 23.7 per 100k residents WV Virginia: no data reported VA Maryland: 2,044 units · 33.1 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: 237 units · 11.2 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 2,772 units · 25.6 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 1,428 units · 31.2 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 3,696 units · 12.1 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
5.093.9
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 York 93.9 /100k
2 Montana 61.8 /100k
3 Minnesota 54.2 /100k
4 Washington 49.8 /100k
5 Colorado 39.3 /100k
6 Maryland 33.1 /100k
7 Louisiana 31.2 /100k
8 North Carolina 25.6 /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.

Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)

Medicare Part D (outpatient prescription) spending for Ocella — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Ocella. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Total Part D spend
$8.8K
Claims incl. refills
250
Beneficiaries
93
Spend / beneficiary
$95.10
Spend / claim
$35.38
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product Kit / multi-component package No longer marketed (per FDA listing data)

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

What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Who lists this product with the FDA?
TEVA PHARMACEUTICALS USA, 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.
← 00555-9123-66 · Teva 00562-7805-01 · Kedrion →
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.