Home › NDC Lookup › Ingredients › Norgestimate And Ethinyl Estradiol › 69238-1551-06
📦image loading
(from DailyMed)

Femynor norgestimate and ethinyl estradiol Kit, 1 kit — NDC 69238-1551-6 (Billing 69238-1551-06)

by Amneal Pharmaceuticals NY LLC · 1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK

This is a package of 1 kit of Femynor norgestimate and ethinyl estradiol Kit from Amneal Pharmaceuticals NY LLC, marketed since Jun 2016 and currently FDA-listed; retail pharmacies pay about $0.1445 per kit (NADAC). It is this product's only package size.

NDC 69238-1551-06
🏷️ FDA NDC (as labeled) 69238-1551-6 billing pads the package 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

⚠️
Other active recalls for Norgestimate And Ethinyl Estradiol (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Sep 2, 2025 — Failed Content Uniformity Specifications (AvKARE) · FDA recall D-0007-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69238-1551-6
Product NDC 69238-1551
11-digit billing NDC 69238155106
NCPDP billing unit EA — each (per item)
RxCUI 240128, 748797, 749860, 1796922
UPC 0369238155167
Application # ANDA203865
SPL Set ID 59bce25b-ee2c-4f06-afff-e5141d063602
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-06-15
Dosage form KIT

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

GPI-14 25990002950310
GPI class Femynor
GCN Seq No 013662
GCN 11300
HICL code 004845
Ingredient (HICL) Norgestimate-Ethinyl Estradiol
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 FEMYNOR 28 TABLET
FDB brand name Femynor
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 013662
  • GCN: 11300
  • GPI-14 (Medi-Span): 25990002950310
  • HICL (First Databank): 004845
  • AHFS class code: 68:12.00.00
  • RxCUI (RxNorm): 240128
Why two NDCs? The FDA registers this code as 69238-1551-6 — a 5-4-1 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 package segment → 69238-1551-06. 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 and estrogens, sequential preparations
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 FEMYNOR 28 TABLET Ingredient Norgestimate-Ethinyl Estradiol

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 $0.145 $0.14 / 1 kit
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
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 Mar 2022 Jul 2022 Nov 2022 $0.182 $0.145
▼ Down 14% over the last 12 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
69238-1551-06 You're viewing this Main listing 1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK 2016-06-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tri-Lo-Sprintec 00093-2140-62 Teva 3 pouches $0.108 AB Availability likely save 25%
Tri-Lo-Mili 65862-0778-28 Aurobindo 1 kit $0.108 AB Availability likely save 25%
Tri-VyLibra Lo 50102-0231-13 Afaxys 1 kit $0.108 AB Availability likely save 25%
Tri-Lo- Estarylla 70700-0120-85 Xiromed, 1 kit $0.108 AB Availability likely save 25%
Tri-Lo-Marzia 68180-0837-73 Lupin 3 pouches $0.108 AB Availability likely save 25%
Estarylla 70700-0119-85 Xiromed, 1 kit $0.115 AB Availability likely save 21%
Sprintec 00555-9016-58 Teva 6 pouches $0.115 AB Availability likely save 21%
VyLibra 50102-0235-11 Afaxys 1 kit $0.115 AB Availability likely save 21%
Mono-Linyah 16714-0360-01 Northstar 1 packet $0.115 AB Availability likely save 21%
Mili 65862-0776-28 Aurobindo 1 kit $0.115 AB Availability likely save 21%
Norgestimate and Ethinyl Estradiol 68462-0309-29 Glenmark 1 kit $0.115 AB Availability likely save 21%
Norgestimate and Ethinyl Estradiol 68180-0840-73 Lupin 3 pouches $0.115 AB Availability likely save 21%
Tri-Mili 65862-0777-28 Aurobindo 1 kit $0.126 AB Availability likely save 12%
Tri-Estarylla 70700-0121-85 Xiromed, 1 kit $0.126 AB Availability likely save 12%
Norgestimate and Ethinyl Estradiol 68462-0565-29 Glenmark 1 kit $0.126 AB Availability likely save 12%
Tri-Sprintec 00555-9018-58 Teva 6 pouches $0.126 AB Availability likely save 12%
Norgestimate and ethinyl estradiol 68180-0838-73 Lupin 1 kit $0.126 AB Availability likely save 12%
Tri-VyLibra 50102-0233-11 Afaxys 1 kit $0.126 AB Availability likely save 12%
Tri-Linyah 16714-0363-01 Northstar 1 packet $0.126 AB Availability likely save 12%
Nymyo 51862-0645-01 Mayne 1 packet $0.135 AB FDA listed save 7%
Tri-Nymyo 51862-0646-01 Mayne 1 packet $0.140 AB FDA listed save 3%
Tri Femynor 69238-1607-06 Amneal 1 kit $0.140 — FDA listed save 3%
Femynorthis 69238-1551-06 Amneal 1 kit $0.144 — FDA listed —
Tri-Sprintec 63187-0458-28 Proficient 6 pouches — AB FDA listed —
Tri-Lo-Marzia 63187-0754-28 Proficient 1 pouch — AB FDA listed —
Sprintec 63187-0911-28 Proficient 1 pouch — AB FDA listed —
Norgestimate and Ethinyl Estradiol 71205-0191-28 Proficient 1 kit — AB FDA listed —
Norgestimate and Ethinyl Estradiol 42291-0553-84 AvKARE 1 kit — AB FDA listed —
Norgestimate and Ethinyl Estradiol 42291-0565-84 AvKARE 1 kit — AB FDA listed —
norgestimate and ethinyl estradiol 42291-0590-84 AvKARE 1 kit — AB FDA listed —
Norgestimate and Ethinyl Estradiol 50090-2603-00 A-S 1 kit — AB FDA listed —
Tri-Lo-Sprintec 71205-0287-28 Proficient 1 pouch — AB FDA listed —
Tri-Lo-Mili 71205-0746-28 Proficient 1 kit — AB FDA listed —
Norgestimate and ethinyl estradiol 79929-0008-07 Naari 1 kit — AB FDA listed —
Tri-Estarylla 63629-2350-01 Bryant 1 kit — AB FDA listed —
Norgestimate and ethinyl estradiol 79929-0009-07 Naari 1 kit — AB FDA listed —
Estarylla 82804-0158-28 Proficient 1 pouch — AB FDA listed —
Tri-Sprintec 68788-6325-02 Preferred 1 pouch — AB FDA listed —
norgestimate and ethinyl estradiol 72789-0435-79 PD-Rx 1 pouch — AB FDA listed —
Mono-Linyah 50090-4881-00 A-S 1 kit — AB FDA listed —
Norgestimate and Ethinyl Estradiol 72789-0434-79 PD-Rx 1 pouch — AB FDA listed —
Tri-Lo-Marzia 50090-2429-00 A-S 1 kit — AB FDA listed —
Estarylla 63629-2349-01 Bryant 1 kit — AB Discontinued —
Sprintec 68788-7429-02 Preferred 1 pouch — AB FDA listed —
Tri-Estarylla 50090-7861-00 A-S 1 kit — AB FDA listed —
Norgestimate and Ethinyl Estradiol 50090-2259-00 A-S 1 kit — AB FDA listed —
Tri-Lo- Estarylla 63629-2351-01 Bryant 1 kit — AB FDA listed —
Mono-Linyah 67296-2329-08 Redpharm 1 kit — 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

🏛️
2016
On the market since
Jun 2016
📍
2026
Currently FDA-listed
10 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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

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

Inactive Ingredients / Excipients

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

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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

LabelerAmneal Pharmaceuticals NY LLC
Application holderNAARI PTE LTD
FDA applicationANDA203865 (ANDA)
Labeler code69238
First marketedJun 2016
Product typeHuman Prescription Drug
Portfolio372 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 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 112 words ▾

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (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 are contraindicated in 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 . Femynor is contraindicated in women over 35 years old who smoke. ( 4 ) Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use.

( 4 )

🎯 Indications and Usage 39 words ▾

1 INDICATIONS AND USAGE Femynor Tablets are indicated for use by females of reproductive potential to prevent pregnancy [ see Clinical Studies (14) ]. Femynor are estrogen/progestin COCs, indicated for use by women 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. ( 2.2 ) Take tablets in the order directed on the blister pack. ( 2.2 ) Do not skip or delay tablet intake. ( 2.2 )

2.1How to Start Femynor Femynor is dispensed in a blister pack [ see How Supplied/Storage and Handling (16) ]. Femynor may be started using either a Day 1 start or a Sunday start (see Table 1). For the first cycle of a Sunday Start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration.

2.2How to Take Femynor Table 1: Instructions for Administration of Femynor Starting COCs in women not currently using hormonal contraception (Day 1 Start or Sunday Start) Important: Consider the possibility of ovulation and conception prior to initiation of this product. Tablet Color: Femynor active tablets are red (Day 1 to Day 21). Femynor has white inactive tablets (Day 22 to Day 28).

Day 1 Start: Take first red “active” tablet without regard to meals on the first day of menses. Take subsequent red “active” tablets once daily at the same time each day for a total of 21 days. Take one white “inactive” tablet daily for 7 days and at the same time of day that red “active” tablets were taken.

Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last white “inactive” tablet) Sunday Start: Take first red “active” tablet without regard to meals on the first Sunday after the onset of menses. Due to the potential risk of becoming pregnant, use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of the patient's first cycle pack of Femynor . Take subsequent red “active” tablets once daily at the same time each day for a total of 21 days.

Take one white “inactive” tablet daily for the following 7 days and at the same time of day that red “active” tablets were taken. Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the Sunday after taking the last white “inactive” tablet) and additional non-hormonal contraceptive is not needed. Switching to Femynor from another oral contraceptive Start on the same day that a new pack of the previous oral contraceptive would have started.

Switching from another contraceptive method to Femynor Start Femynor : Transdermal patch On the day when next application would have been scheduled Vaginal ring On the day when next insertion would have been scheduled Injection On the day when next injection would have been scheduled Intrauterine contraceptive On the day of removal If the IUD is not removed on first day of the patient's menstrual cycle, additional non-hormonal contraceptive (such as condoms and spermicide) is needed for the first seven days of the first cycle pack.

Implant On the day of removal Complete instructions to facilitate patient counseling on proper tablet usage are located in the FDA-approved Patient Labeling. Starting Femynor after Abortion or Miscarriage First-trimester After a first-trimester abortion or miscarriage, Femynor may be started immediately. An additional method of contraception is not needed if Femynor is started immediately.

If Femynor is not started within 5 days after termination of the pregnancy, the patient should use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of her first cycle pack of Femynor. Second-trimester Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start Femynor, following the instructions in Table 1 for Day 1 or Sunday start, as desired.

If using Sunday start, use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of the patient's first cycle pack of Femynor. [ See Contraindications (4) , Warnings and Precautions (5.1) , and FDA-Approved Patient Labeling .] Starting Femynor after Childbirth Do… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 93 words ▾

3 DOSAGE FORMS AND STRENGTHS Femynor tablets are available in a blister pack containing 28 tablets in the following order: 21 red, round, biconvex, film-coated tablets debossed with "E3" on one side of the tablet, containing 0.25 mg norgestimate and 0.035 mg ethinyl estradiol 7 white, round, biconvex, film-coated tablets (non-hormonal placebo) debossed with "C2" on one side, containing inert ingredients Femynor consists of 28 round, biconvex, film-coated tablets in the following order ( 3 ): 21 red tablets each containing 0.25 mg norgestimate and 0.035 mg ethinyl estradiol 7 white tablets (inert)

⛔ Contraindications ~1 min read ▾

4 CONTRAINDICATIONS Do not prescribe Femynor to women who are known to have the following conditions: 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 inherited or acquired hypercoagulopathies [ 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 uncontrolled hypertension [ see Warnings and Precautions (5.3) ] Have diabetes mellitus with vascular disease [ see Warnings and Precautions (5.5) ] Have headaches with focal neurological symptoms or migraine headaches with aura [ see Warnings and Precautions (5.6) ] Women over age 35 with any migraine headaches [ see Warnings and Precautions (5.6) ] Liver tumors, benign or malignant, or liver disease [ see Warnings and Precautions (5.2) ] Undiagnosed abnormal uterine bleeding [ see Warnings and Precautions (5.7) ] Pregnancy, because there is no reason to use COCs during pregnancy [ see Warnings and Precautions (5.8) and Use in Specific Populations (8.1) ] Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past [ see Warnings and Precautions (5.10) ] A high risk of arterial or venous thrombotic diseases ( 4 ) Liver tumors or liver disease ( 4 ) Undiagnosed abnormal uterine bleeding ( 4 ) Pregnancy ( 4 ) Breast cancer or other estrogen- or progestin-sensitive cancer ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Thromboembolic Disorders and Other Vascular Problems : Stop Femynor 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 ) Liver disease : Discontinue Femynor if jaundice occurs. ( 5.2 ) High blood pressure : If used in women with well-controlled hypertension monitor blood pressure and stop Femynor if blood pressure rises significantly. ( 5.3 ) Carbohydrate and lipid metabolic effects : Monitor prediabetic and diabetic women taking Femynor.

Consider an alternate contraceptive method for women with uncontrolled dyslipidemia. ( 5.5 ) Headache : Evaluate significant change in headaches and discontinue Femynor if indicated. ( 5.6 ) Bleeding Irregularities and Amenorrhea : Evaluate irregular bleeding or amenorrhea.

( 5.7 )

5.1Thromboembolic Disorders and Other Vascular Problems Stop Femynor if an arterial thrombotic event or venous thromboembolic (VTE) event occurs. Stop Femynor if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately [ see Adverse Reactions (6.2) ].

If feasible, stop Femynor at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE as well as during and following prolonged immobilization. Start Femynor no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum VTE decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.

The use of COCs increases the risk of VTE. However, pregnancy increases the risk of VTE as much or more than the use of COCs. The risk of VTE in women using COCs is 3 to 9 cases per 10,000 woman-years.

The risk of VTE is highest during the first year of use of COCs and when restarting hormonal contraception after a break of 4 weeks or longer. The risk of thromboembolic disease due to COCs gradually disappears after use is discontinued. Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events.

COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes). This risk increases with age, particularly in women over 35 years of age who smoke. Use COCs with caution in women with cardiovascular disease risk factors.

5.2Liver Disease Impaired Liver Function Do not use Femynor in women with liver disease, such as acute viral hepatitis or severe (decompensated) cirrhosis of liver [ see Contraindications (4) ]. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded. Discontinue Femynor if jaundice develops.

Liver Tumors Femynor is contraindicated in women with benign and malignant liver tumors [ see Contraindications (4) ]. Hepatic adenomas are associated with COC use. An estimate of the attributable risk is 3.3 cases/100,000 COC users.

Rupture of hepatic adenomas may cause death through intra-abdominal hemorrhage. Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (>8 years) COC users. However, the risk of liver cancers in COC users is less than one case per million users.

5.3High Blood Pressure Femynor is contraindicated in women with uncontrolled hypertension or hypertension with vascular disease [ see Contraindications (4) ]. For women with well-controlled hypertension, monitor blood pressure and stop Femynor if blood pressure rises significantly. An increase in blood pressure has been reported in women taking COCs, and this increase is more likely in older women with extended duration of use.

The incidence of hypertension increases with increasing conce… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions with the use of COCs are discussed elsewhere in 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 (5.2) ] Adverse reactions commonly reported by COC users are: Irregular uterine bleeding Nausea Breast tenderness Headache The most common adverse reactions reported during clinical trials (≥2%) were: headache/migraine, abdominal/gastrointestinal pain, vaginal infection, genital discharge, breast issues (including breast pain, discharge, and enlargement), mood disorders (including depression and mood altered), flatulence, nervousness, rash.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals LLC at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trial 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 clinical practice. The safety of Femynor was evaluated in 1,647 healthy women of child-bearing potential who participated in 3 clinical trials and received at least 1 dose of Femynor for contraception. Two trials were randomized active-controlled trials and 1 was an uncontrolled open-label trial.

In all 3 trials, subjects were followed for up to 24 cycles. Common Adverse Reactions (≥ 2% of subjects) : The most common adverse reactions reported by at least 2% of the 1,647 women were the following in order of decreasing incidence: headache/migraine (32.9%), abdominal/gastrointestinal pain (7.8%), vaginal infection (8.4%), genital discharge (6.8%), breast issues (including breast pain, discharge, and enlargement) (6.3%), mood disorders (including depression and mood altered) (5.0%), flatulence (3.2%), nervousness (2.9%), and rash (2.6%).

Adverse Reactions Leading to Study Discontinuation : Over the three trials, between 11 to 21% of subjects discontinued the trial due to an adverse reaction. The most common adverse reactions (≥1%) leading to discontinuation were: metrorrhagia (6.9%), nausea/vomiting (5.0%), headache (4.1%), mood disorders (including depression and mood altered) (2.4%), premenstrual syndrome (1.7%), hypertension (1.4%), breast pain (1.4%), nervousness (1.3%), amenorrhea (1.1%), dysmenorrhea (1.1%), weight increased (1.1%), and flatulence (1.1%).

Serious Adverse Reactions : breast cancer (1 subject), mood disorders including depression, irritability, and mood swings (1 subject), myocardial infarction (1 subject), and venous thromboembolic events including pulmonary embolism (1 subject) and deep vein thrombosis (DVT) (1 subject).

6.2Postmarketing Experience The following additional adverse drug reactions have been reported from worldwide postmarketing experience with norgestimate/ethinyl estradiol. 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. Infections and Infestations : Urinary tract infection; Neoplasms Benign, Malignant and Unspecified (Incl.

Cysts and Polyps) : Breast cancer, benign breast neoplasm, hepatic adenoma, focal nodular hyperplasia, breast cyst; Immune System Disorders : Hypersensitivity; Metabolism and Nutrition Disorders : Dyslipidemia; Psychiatric Disorders : Anxiety, insomnia; Nervous System Disorders : Syncope, convulsion, paresthesia, dizziness; Eye Disorders : Visual impairment, dry eye, contact lens intolerance; Ear and Labyrinth Disorders : Vertigo; Cardiac Disorders : Tachycardia, palpitations; Vascular Events : Deep vein thrombosis, pulmonary embolism, retinal vascular thrombosis, hot flush; Arterial Events : Arterial thromboembolism, myocardial infarction, cereb… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Consult the labeling of concurrently used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. No drug-drug interaction studies were conducted with Femynor. Drugs or herbal products that induce certain enzymes including 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 decreasing the plasma concentrations of COCs : Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the plasma concentrations of COCs and potentially diminish 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, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St.

John's wort. Interactions between hormonal 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.

Colesevelam : Colesevelam, a bile acid sequestrant, given together with a COC, has been shown to significantly decrease the AUC of EE. The drug interaction between the contraceptive and colesevelam was decreased when the two drug products were given 4 hours apart. Substances increasing the plasma concentrations of COCs : Co-administration of atorvastatin or rosuvastatin and certain COCs containing ethinyl estradiol (EE) increase AUC values for EE by approximately 20 to 25%.

Ascorbic acid and acetaminophen may increase plasma EE concentrations, possibly by inhibition of conjugation. CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase plasma hormone concentrations. 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/or progestin have been noted in some cases of co-administration with HIV protease inhibitors (decrease [e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir] or increase [e.g., indinavir and atazanavir/ritonavir])/HCV protease inhibitors (decrease [e.g., boceprevir and telaprevir]) or with non-nucleoside reverse transcriptase inhibitors (decrease [e.g., nevirapine] or increase [e.g., etravirine]).

7.2Effects of Combined Oral Contraceptives on Other Drugs COCs containing EE may inhibit the metabolism of other compounds (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole) and increase their plasma concentrations. COCs have been shown to decrease plasma concentrations of acetaminophen, clofibric acid, morphine, salicylic acid, temazepam and lamotrigine. Significant decrease in plasma concentration of lamotrigine has been shown, likely due to induction of lamotrigine glucuronidation.

This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary. Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because the serum concentration of thyroid-binding globulin increases with use of COCs.

7.3Interference with Laboratory Tests The use of contraceptive steroids may influence the results of certain laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins.

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS Nursing mothers: Not recommended; can decrease milk production. ( 8.3 )

8.1Pregnancy There is little or no increased risk of birth defects in women who inadvertently use COCs during early 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 low dose COCs prior to conception or during early pregnancy. Do not administer COCs to induce withdrawal bleeding as a test for pregnancy.

Do not use COCs during pregnancy to treat threatened or habitual abortion.

8.3Nursing Mothers Advise the nursing mother to use other forms of contraception, when possible, until she has weaned her child. COCs can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. Small amounts of oral contraceptive steroids and/or metabolites are present in breast milk.

8.4Pediatric Use Safety and efficacy of Femynor Tablets has been established in women of reproductive age. Efficacy is expected to be the same for post-pubertal 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 Femynor has not been studied in postmenopausal women and are not indicated in this population.

8.6Hepatic Impairment The pharmacokinetics of Femynor has not been studied in subjects with hepatic impairment. However, steroid hormones may be poorly metabolized in patients with hepatic impairment. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded. [ See Contraindications (4) and Warnings and Precautions (5.2) .]

8.7Renal Impairment The pharmacokinetics of Femynor has not been studied in women with renal impairment.

🤰 Pregnancy 82 words ▾

8.1Pregnancy There is little or no increased risk of birth defects in women who inadvertently use COCs during early 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 low dose COCs prior to conception or during early pregnancy. Do not administer COCs to induce withdrawal bleeding as a test for pregnancy.

Do not use COCs during pregnancy to treat threatened or habitual abortion.

🧒 Pediatric Use 48 words ▾

8.4Pediatric Use Safety and efficacy of Femynor Tablets has been established in women of reproductive age. Efficacy is expected to be the same for post-pubertal 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 Femynor has not been studied in postmenopausal women and are not indicated in this population.

🆘 Overdosage 29 words ▾

10 OVERDOSAGE There have been no reports of serious ill effects from overdosage of oral contraceptives, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action COCs lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.

12.2Pharmacodynamics No specific pharmacodynamic studies were conducted with Femynor.

12.3Pharmacokinetics Absorption Norgestimate (NGM) and EE are rapidly absorbed following oral administration. NGM is rapidly and completely metabolized by first pass (intestinal and/or hepatic) mechanisms to norelgestromin (NGMN) and norgestrel (NG), which are the major active metabolites of norgestimate. Peak serum concentrations of NGMN and EE are generally reached by 2 hours after administration of Femynor.

Accumulation following multiple dosing of the 250 mcg NGM / 35 mcg EE dose is approximately 2-fold for NGMN and EE compared with single dose administration. The pharmacokinetics of NGMN is dose-proportional following NGM doses of 180 mcg to 250 mcg. Steady-state concentration of EE is achieved by Day 7 of each dosing cycle.

Steady-state concentrations of NGMN and NG are achieved by Day 21. Non-linear accumulation (approximately 8 fold) of NG is observed as a result of high-affinity binding to SHBG, which limits its biological activity (Table 3). Table 3: Summary of NGMN, NG and EE pharmacokinetic parameters.

Mean (SD) Pharmacokinetic Parameters of Femynor During a Three Cycle Study Analyte Cycle Day C max t max (h) AUC 0-24h t 1/2 (h) NGMN 1 1 1.78 (0.397) 1.19 (0.250) 9.90 (3.25) 18.4 (5.91) 3 21 2.19 (0.655) 1.43 (0.680) 18.1 (5.53) 24.9 (9.04) NG 1 1 0.649 (0.49) 1.42 (0.69) 6.22 (2.46) 37.8 (14) 3 21 2.65 (1.11) 1.67 (1.32) 48.2 (20.5) 45 (20.4) EE 1 1 92.2 (24.5) 1.2 (0.26) 629 (138) 10.1 (1.90) 3 21 147 (41.5) 1.13 (0.23) 1210 (294) 15 (2.36) C max = peak serum concentration, t max = time to reach peak serum concentration, AUC 0–24h = area under serum concentration vs time curve from 0 to 24 hours, t 1/2 = elimination half-life, NC = not calculated.

NGMN and NG: C max = ng/mL, AUC 0–24h = h·ng/mL EE: C max = pg/mL, AUC 0-24h = h·pg/mL Food Effect The effect of food on the pharmacokinetics of Femynor has not been studied. Distribution NGMN and NG are highly bound (>97%) to serum proteins. NGMN is bound to albumin and not to SHBG, while NG is bound primarily to SHBG.

EE is extensively bound (>97%) to serum albumin and induces an increase in the serum concentrations of SHBG. Metabolism NGM is extensively metabolized by first-pass mechanisms in the gastrointestinal tract and/or liver. NGM's primary active metabolite is NGMN.

Subsequent hepatic metabolism of NGMN occurs and metabolites include NG, which is also active, and various hydroxylated and conjugated metabolites. Although NGMN and its metabolites inhibit a variety of P450 enzymes in human liver microsomes, under the recommended dosing regimen, the in vivo concentrations of NGMN and its metabolites, even at the peak serum levels, are relatively low compared to the inhibitory constant (Ki). EE is also metabolized to various hydroxylated products and their glucuronide and sulfate conjugates.

Excretion The metabolites of NGMN and EE are eliminated by renal and fecal pathways. Following administration of 14 C-norgestimate, 47% (45–49%) and 37% (16–49%) of the administered radioactivity was eliminated in the urine and feces, respectively. Unchanged NGM was not detected in the urine.

In addition to 17-deacetyl norgestimate, a number of metabolites of NGM have been identified in human urine following administration of radiolabeled NGM. These include 18, 19-Dinor-17-pregn-4-en-20-yn-3-one,17-hydroxy-13-ethyl,(17α)-(-);18,19-Dinor-5β-17-pregnan-20-yn,3α,17β-dihydroxy-13-ethyl,(17α), various hydroxylated metabolites and conjugates of these metabolites.

🧬 Mechanism of Action 36 words ▾

12.1Mechanism of Action COCs lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.

📦 How Supplied / Storage and Handling 96 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Femynor™ (norgestimate and ethinyl estradiol tablets, USP) is available in a blister pack (NDC 69238-1551-6) Each blister pack (28 tablets) contains in the following order: 21 red, round, biconvex, film-coated tablets debossed with "E3" on one side, containing 0.25 mg norgestimate and 0.035 mg ethinyl estradiol 7 white, round, biconvex, film-coated tablets (non-hormonal placebo) debossed with "C2" on one side containing inert ingredients Keep out of reach of children.

16.2Storage Conditions Store at 20° to 25°C (68° to 77°F) [see USP controlled Room Temperature]. Protect from light.

📋 Description 107 words ▾

11 DESCRIPTION Femynor™ (norgestimate and ethinyl estradiol tablets, USP) is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)-(+)-) and ethinyl estradiol is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). Each red “active” tablet contains 0.25 mg of norgestimate and 0.035 mg of ethinyl estradiol.

Inactive ingredients include croscarmellose sodium, ferric oxide red, hydrogenated cottonseed oil, hydroxypropylcellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, talc, and titanium dioxide. Each white placebo tablet contains only inert ingredients, as follows: hydrogenated cottonseed oil, hydroxypropylcellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium, talc and titanium dioxide. norgestimate formula ethinyl estradiol

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information and Instructions for Use). Counsel patients about the following information: 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 [ see Boxed Warning ]. 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 [ see Warnings and Precautions (5.1) ].

Femynor does not protect against HIV infection (AIDS) and other sexually transmitted infections. Femynor is not to be used during pregnancy; if pregnancy occurs during use of Femynor instruct the patient to stop further use [ see Warnings and Precautions (5.8) ]. Take one tablet daily by mouth at the same time every day.

Instruct patients what to do in the event tablets are missed [ see Dosage and Administration (2.2) ]. Use a back-up or alternative method of contraception when enzyme inducers are used with Femynor [ see Drug Interactions (7.1) ]. COCs may reduce breast milk production; this is less likely to occur if breastfeeding is well established [ see Use in Specific Populations (8.3) ].

Women who start COCs postpartum, and who have not yet had a period, should use an additional method of contraception until they have taken a red “active” tablet for 7 consecutive days [ see Dosage and Administration (2.2) ]. Amenorrhea may occur. Consider pregnancy in the event of amenorrhea at the time of the first missed period.

Rule out pregnancy in the event of amenorrhea in two or more consecutive cycles [ see Warnings and Precautions (5.7) ]. Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 05-2016-00

🍼 Nursing Mothers 62 words ▾

8.3Nursing Mothers Advise the nursing mother to use other forms of contraception, when possible, until she has weaned her child. COCs can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. Small amounts of oral contraceptive steroids and/or metabolites are present in breast milk.

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Absorption Norgestimate (NGM) and EE are rapidly absorbed following oral administration. NGM is rapidly and completely metabolized by first pass (intestinal and/or hepatic) mechanisms to norelgestromin (NGMN) and norgestrel (NG), which are the major active metabolites of norgestimate. Peak serum concentrations of NGMN and EE are generally reached by 2 hours after administration of Femynor.

Accumulation following multiple dosing of the 250 mcg NGM / 35 mcg EE dose is approximately 2-fold for NGMN and EE compared with single dose administration. The pharmacokinetics of NGMN is dose-proportional following NGM doses of 180 mcg to 250 mcg. Steady-state concentration of EE is achieved by Day 7 of each dosing cycle.

Steady-state concentrations of NGMN and NG are achieved by Day 21. Non-linear accumulation (approximately 8 fold) of NG is observed as a result of high-affinity binding to SHBG, which limits its biological activity (Table 3). Table 3: Summary of NGMN, NG and EE pharmacokinetic parameters.

Mean (SD) Pharmacokinetic Parameters of Femynor During a Three Cycle Study Analyte Cycle Day C max t max (h) AUC 0-24h t 1/2 (h) NGMN 1 1 1.78 (0.397) 1.19 (0.250) 9.90 (3.25) 18.4 (5.91) 3 21 2.19 (0.655) 1.43 (0.680) 18.1 (5.53) 24.9 (9.04) NG 1 1 0.649 (0.49) 1.42 (0.69) 6.22 (2.46) 37.8 (14) 3 21 2.65 (1.11) 1.67 (1.32) 48.2 (20.5) 45 (20.4) EE 1 1 92.2 (24.5) 1.2 (0.26) 629 (138) 10.1 (1.90) 3 21 147 (41.5) 1.13 (0.23) 1210 (294) 15 (2.36) C max = peak serum concentration, t max = time to reach peak serum concentration, AUC 0–24h = area under serum concentration vs time curve from 0 to 24 hours, t 1/2 = elimination half-life, NC = not calculated.

NGMN and NG: C max = ng/mL, AUC 0–24h = h·ng/mL EE: C max = pg/mL, AUC 0-24h = h·pg/mL Food Effect The effect of food on the pharmacokinetics of Femynor has not been studied. Distribution NGMN and NG are highly bound (>97%) to serum proteins. NGMN is bound to albumin and not to SHBG, while NG is bound primarily to SHBG.

EE is extensively bound (>97%) to serum albumin and induces an increase in the serum concentrations of SHBG. Metabolism NGM is extensively metabolized by first-pass mechanisms in the gastrointestinal tract and/or liver. NGM's primary active metabolite is NGMN.

Subsequent hepatic metabolism of NGMN occurs and metabolites include NG, which is also active, and various hydroxylated and conjugated metabolites. Although NGMN and its metabolites inhibit a variety of P450 enzymes in human liver microsomes, under the recommended dosing regimen, the in vivo concentrations of NGMN and its metabolites, even at the peak serum levels, are relatively low compared to the inhibitory constant (Ki). EE is also metabolized to various hydroxylated products and their glucuronide and sulfate conjugates.

Excretion The metabolites of NGMN and EE are eliminated by renal and fecal pathways. Following administration of 14 C-norgestimate, 47% (45–49%) and 37% (16–49%) of the administered radioactivity was eliminated in the urine and feces, respectively. Unchanged NGM was not detected in the urine.

In addition to 17-deacetyl norgestimate, a number of metabolites of NGM have been identified in human urine following administration of radiolabeled NGM. These include 18, 19-Dinor-17-pregn-4-en-20-yn-3-one,17-hydroxy-13-ethyl,(17α)-(-);18,19-Dinor-5β-17-pregnan-20-yn,3α,17β-dihydroxy-13-ethyl,(17α), various hydroxylated metabolites and conjugates of these metabolites.

🧬 Pharmacodynamics 10 words ▾

12.2Pharmacodynamics No specific pharmacodynamic studies were conducted with Femynor.

🔬 Clinical Studies 94 words ▾

14 CLINICAL STUDIES In three US clinical trials with Femynor, 1,651 women aged 18 to 38 years were studied for up to 24 cycles, proving a total of 24,272 cycles of exposure. The racial demographic was about 73 to 86% Caucasian, 8 to 13% African-American, 6 to 14% Hispanic with the remainder Asian or Other (≤1%). There were no exclusions on the basis of weight; the weight range for women treated was 82 to 303 lbs, with a mean weight of about 135 lbs.

The pregnancy rate was approximately 1 pregnancy per 100 women-years.

🧪 Nonclinical Toxicology 23 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility [ See Warnings and Precautions (5.2) , and Use in Specific Populations (8.1) .]

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 20 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility [ See Warnings and Precautions (5.2) , and Use in Specific Populations (8.1) .]

📄 Patient Package Insert ~3 min read ▾

Patient Information FEMYNOR™ (feh’ mi nore) (norgestimate and ethinyl estradiol tablets, USP) What is the most important information I should know about Femynor ? Do not use Femynor if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects from hormonal birth control pills, including death from heart attack, blood clots or stroke.

This risk increases with age and the number of cigarettes you smoke. What is Femynor ? Femynor is a birth control pill (oral contraceptive) used by women to prevent pregnancy.

How does Femynor work for contraception? 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 clinical studies, about 1 out of 100 women may get pregnant during the first year they use Femynor. 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. Who should not take Femynor ?

Do not take Femynor if you: smoke and are over 35 years of age had blood clots in your arms, legs, lungs, or eyes had a problem with your blood that makes it clot more than normal have certain heart valve problems or irregular heart beat that increases your risk of having blood clots had a stroke had a heart attack have high blood pressure that cannot be controlled by medicine have diabetes with kidney, eye, nerve, or blood vessel damage have certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision, or any migraine headaches if you are over 35 years of age have liver problems, including liver tumors have any unexplained vaginal bleeding are pregnant had breast cancer or any cancer that is sensitive to female hormones If any of these conditions happen while you are taking Femynor , stop taking Femynor right away and talk to your healthcare provider.

Use non-hormonal contraception when you stop taking Femynor . What should I tell my healthcare provider before taking Femynor ? Tell your healthcare provider if you: are pregnant or think you may be pregnant are depressed now or have been depressed in the past had yellowing of your skin or eyes (jaundice) caused by pregnancy (cholestasis of pregnancy) are breastfeeding or plan to breastfeed.

Femynor may decrease the amount of breast milk you make. A small amount of the hormones in Femynor may pass into your breast milk. Talk to your healthcare provider about the best birth control method for you while breastfeeding.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Femynor may affect the way other medicines work, and other medicines may affect how well Femynor works. Know the medicines you take.

Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How should I take Femynor ? Read the Instructions for Use at the end of this Patient Information.

What are the possible serious side effects of Femynor ? Like pregnancy, Femynor may cause serious side effects, including blood clots in your lungs, heart attack, or a stroke that may lead to death. Some other examples of serious blood clots include blood clots in the legs or eyes.

Serious blood clots can happen especially if you smoke, are obese, or are older than 35 years of age. Serious blood clots are more likely to happen when you: first start taking birth control pills restart the same or different birth control pills after not using them for a month or more Call your healthcare provider or go to a hospital emerge… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

Instructions For Use FEMYNOR™ (feh’ mi nore) (norgestimate and ethinyl estradiol tablets, USP) Important Information about taking Femynor Take 1 pill every day at the same time. Take the pills in the order directed on your blister pack. Do not skip your pills, even if you do not have sex often.

If you miss pills (including starting the pack late) you could get pregnant . The more pills you miss, the more likely you are to get pregnant. If you have trouble remembering to take Femynor, talk to your healthcare provider.

When you first start taking Femynor, spotting or light bleeding in between your periods may occur. Contact your healthcare provider if this does not go away after a few months. You may feel sick to your stomach (nauseous), especially during the first few months of taking Femynor.

If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If your nausea does not go away, call your healthcare provider.

Missing pills can also cause spotting or light bleeding, even when you take the missed pills later. On the days you take 2 pills to make up for missed pills (see What should I do if I miss any Femynor pills? below), you could also feel a little sick to your stomach. It is not uncommon to miss a period.

However, if you miss a period and have not taken Femynor according to directions, or miss 2 periods in a row, or feel like you may be pregnant, call your healthcare provider. If you have a positive pregnancy test, you should stop taking Femynor. If you have vomiting or diarrhea within 3 to 4 hours of taking your pill, take another pill of the same color from your extra blister pack.

If you do not have an extra blister pack, take the next pill in your blister pack. Continue taking all your remaining pills in order. Start the first pill of your next blister pack the day after finishing your current blister pack.

This will be 1 day earlier than originally scheduled. Continue on your new schedule. If you have vomiting or diarrhea for more than 1 day, your birth control pills may not work as well.

Use an additional birth control method, like condoms and a spermicide, until you check with your healthcare provider. Stop taking Femynor at least 4 weeks before you have major surgery and do not restart after the surgery without asking your healthcare provider. Be sure to use other forms of contraception (like condoms and spermicide) during this time period.

Before you start taking Femynor : Decide what time of day you want to take your pill. It is important to take it at the same time every day and in the order as directed on your blister pack. Have backup contraception (condoms and spermicide) available and if possible, an extra full pack of pills as needed.

When should I start taking Femynor ? If you start taking Femynor and you have not used a hormonal birth control method before: There are 2 ways to start taking your birth control pills. You can either start on a Sunday (Sunday Start) or on the first day (Day 1) of your natural menstrual period (Day 1 Start).

Your healthcare provider should tell you when to start taking your birth control pill. If you use the Sunday Start, use non-hormonal back-up contraception such as condoms and spermicide for the first 7 days that you take Femynor. You do not need back-up contraception if you use the Day 1 Start.

If you start taking Femynor and you are switching from another birth control pill: Start your new Femynor pack on the same day that you would start the next pack of your previous birth control method. Do not continue taking the pills from your previous birth control pack. If you start taking Femynor and previously used a vaginal ring or transdermal patch: Start using Femynor on the day you would have reapplied the next ring or patch.

If you start taking Femyno r and you are switching from a progestin-only method such as an implant or injection: Start taking Femynor on the day of removal of your implant or on the day when you would have had you… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 6 words ▾

PRINCIPAL DISPLAY PANEL carton

blister card

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

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Femynor (this brand).

Top reported reactions

Pregnancy On Oral Contraceptive56
Nausea41
Vomiting31
Drug Interaction29
Headache29
Product Quality Issue29
Pain26

Age at onset

Adolescent4
Adult40

Reporter sex

659 reports
Male · 0%
Female · 100%

Serious outcomes

Hospitalization124
Life-threatening25
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 53 10
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product Kit / multi-component package

Kit / multi-component package

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

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) ✓ Available
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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 Amneal Pharmaceuticals NY LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Amneal Pharmaceuticals NY LLC 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.
← 69238-1544-01 · Amneal 69238-1552-03 · Amneal →
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.