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Norethindrone and ethinyl estradiol and ferrous fumarate Kit — NDC 79929-0005-07 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Norethindrone and ethinyl estradiol and ferrous fumarate Kit — NDC 79929-005-07 (Billing 79929-0005-07)

by Naari Pte Limited · 3 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK

This is a package of Norethindrone and ethinyl estradiol and ferrous fumarate Kit from Naari Pte Limited, marketed since Dec 2022 and currently FDA-listed. It is this product's only package size.

NDC 79929-0005-07
🏷️ FDA NDC (as labeled) 79929-005-07 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 79929-005-07 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
79929 labeler · 005 product · 07 package
Package marketed since
Dec 31, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7992900507 7
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 79929-005-07
Product NDC 79929-005
11-digit billing NDC 79929000507
RxCUI 433718, 1095223, 1095224
Application # ANDA207066
SPL Set ID 1f7a19f1-fd30-4bd2-aab6-926d911d2579
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-12-31
Dosage form KIT
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 433718
Why two NDCs? The FDA registers this code as 79929-005-07 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 79929-0005-07. 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 Estrogen class.

Pharmacologic class Estrogen
Drug family (ATC) Progestogens and estrogens, sequential preparations, Natural and semisynthetic estrogens, plain, Estrogens
How it works Estrogen Receptor Agonists
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

📖 What it is MedlinePlus · NLM

Oral contraceptives (birth-control pills) containing ethinyl estradiol (an estrogen) and norethindrone (a progestin) are used to prevent pregnancy. Estrogen and progestin are two female sex hormones. Combinations of estrogen and progestin work mainly by preventing ovulation (the release of eggs from the ovaries). Oral contraceptives are an effective method of birth control, but they do not prevent the spread of human immunodeficiency virus (HIV, the virus that causes acquired immunodeficiency syndrome [AIDS]) and other sexually transmitted diseases.

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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
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.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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
79929-0005-07 You're viewing this Main listing 3 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK 2022-12-31 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Norethindrone and ethinyl estradiol and ferrous fumaratethis 79929-0005-07 Naari 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

🏛️
2022
On the market since
Dec 2022
📍
2026
Currently FDA-listed
4 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.

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

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerNaari Pte Limited
Application holderNAARI PTE LTD
FDA applicationANDA207066 (ANDA)
Labeler code79929
First marketedDec 2022
Product typeHuman Prescription Drug
Portfolio8 products on file

More NDCs from Naari Pte Limited labeler code 79929

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 127 words ▾

WARNING: CIGARETTE SMOKING AND SERIOU S 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. Norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets are contraindicated in w omen over 35 years old who smoke . ( 4 ) Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive s (COC) use .

( 4 )

🎯 Indications and Usage 59 words ▾

1. INDICATIONS AND USAGE Norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets are indicated for use by females of reproductive potential to prevent pregnancy. Norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets are progestin/estrogen COC 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 by mouth at the same time every day. Norethindrone and ethinyl estradiol tablets (chewable) may be chewed or swallowed. ( 2.1 ) Take tablets in the order directed on the blister pack. ( 2.1 )

2.1How to Start Norethindrone and Ethinyl Estradiol Tablets (chewable) 0.4 mg/0.035 mg and Ferrous Fumarate Tablets Norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets are dispensed in a blister card [see How Supplied/Storage and Handling (16) ] . Norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets 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 Norethindrone and Ethinyl Estradiol Tablets (chewable) 0.4 mg/0.035 mg and Ferrous Fumarate Tablets The Norethindrone and ethinyl estradiol tablets, USP may be swallowed whole or chewed. If Norethindrone and ethinyl estradiol tablets, USP are chewed, the patient should drink a full glass (8 ounces) of liquid immediately after swallowing. Table 1: Instructions for Administration of Norethindrone and Ethinyl Estradiol Tablets (chewable) 0.4 mg/0.035 mg and Ferrous Fumarate Tablets Starting CHCs 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: Norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg active tablets are white to off white (Day 1 to Day 21). Ferrous fumarate tablets placebo tablets are brown (Day 22 to Day 28). Day 1 Start: Take first white to off white active tablet on the first day of menses.

Take subsequent white to off white active tablets once daily at the same time each day for a total of 21 days. Take one brown placebo tablet daily for 7 days and at the same time of day that 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 inactive tablet).

Sunday Start: Take first active tablet 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 norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets. Take subsequent white to off white active tablets once daily at the same time each day for a total of 21 days.

Take one brown placebo tablet daily for the following 7 days and at the same time of day that 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 inactive tablet) and additional non-hormonal contraceptive is not needed. Switching to norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets from another hormonal contraceptive Start on the same day that a new pack of the previous hormonal contraceptive would have started.

Switching from another contraceptive method to norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets Start norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets: 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… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 162 words ▾

3. DOSAGE FORMS AND STRENGTHS Norethindrone and ethinyl estradiol tablets, USP (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets are available in blister cards. Each blister card contains 28 tablets in the following order: 21 active tablets: white to off-white, round, flat faced beveled edge, uncoated tablets debossed with "EJ1" on one side and plain on other side (0.4 mg norethindrone, USP and 0.035 mg ethinyl estradiol, USP).

7 inert tablets: brown, round, flat faced beveled edge, uncoated tablets debossed with 'EJ2' on one side and plain on other side; tablets may have mottled appearance on either of the surface. Norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets consists of 28 tablets in the following order ( 3 ): 21 white to off white tablets (active), each containing 0.4 mg norethindrone and 0.035 mg ethinyl estradiol 7 brown tablets (non-hormonal placebo), each containing 75 mg ferrous fumarate.

The ferrous fumarate tablets do not serve any therapeutic purpose.

⛔ Contraindications ~2 min read ▾

4. CONTRA IN DIC A TIONS Norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg is contraindicated in females who are known to have or develop 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 (5.4) ] ▪ Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.6) ] ▪ Have headaches with focal neurological symptoms or have migraine headaches with aura [see Warnings and Precautions (5.7) ] ▪ Women over age 35 with any migraine headaches [see Warnings and Precautions (5.7) ] Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions (5.2) ] Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.9) ] Pregnancy, because there is no reason to use COCs during pregnancy [see Warnings and Precautions (5.9) and Use in Specific Populations (8.1) ].

Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see Warnings and Precautions (5.11)] Hypersensitivity to any of the components. 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 (5.3)] 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 Thrombotic Disorders and Other Vascular Problems: Stop norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets if a thrombotic event occurs. Stop at least 4 weeks before 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 norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets if jaundice occurs ( 5.2 ) High blood pressure: If used in women with well-controlled hypertension, monitor blood pressure and stop norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets if blood pressure rises significantly.( 5.3 ) Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets.

Consider an alternative contraceptive method for women with uncontrolled dyslipidemia ( 5.5 ) Headache: Evaluate significant change in headaches and discontinue norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets if indicated ( 5.6 ) Bleeding Irregularities and Amenorrhea: Evaluate irregular bleeding or amenorrhea ( 5.7 )

5.1Thrombotic Disorders and Other Vascular Problems Stop norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets if an arterial thrombotic event or venous thromboembolic (VTE) event occurs. Stop norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.

If feasible, stop norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets 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 the following prolonged immobilization. Start norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets 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 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). The 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 norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets 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 norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets if jaundice develops.

Liver Tumors Norethindrone and ethinyl estradiol tablets… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~1 min read ▾

6. ADVERSE REACTIONS

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 1). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 1). 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 1 Risk of Breast Cancer with Combined Oral Contraceptive Use 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 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 (5.2) ] The following adverse reactions are commonly reported by COC users. Because these reactions are voluntarily reported by from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Irregular uterine bleeding Nausea Breast tenderness Headache The most common adverse reactions were: irregular uterine bleeding, nausea, breast tenderness, and headache.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. figure-01

🔄 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. 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 method 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 and potentially diminishing the efficacy 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 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, 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., 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 [see Warnings and Precautions (5.11) ].

7.3Concomitant Use with HCV Combination Therapy – Liver Enzyme Elevation Do not co-administer FEMCON Fe with HCV drug combinations containing ombitasvir/ paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations [see Warnings and Precautions (5.3)].

7.4Interference with Laboratory Tests The use of contraceptive steroids may influen… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~2 min read ▾

8. USE IN SPECIFIC POPULATIONS Nursing mothers: Advise use of another contraceptive method. Norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets 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 use 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 norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets have been established in women of reproductive age. Efficacy is expected to be the same in post-pubertal adolescents under the age of 18 years as for users 18 years and older. Use of this product before menarche is not indicated.

8.5Geriatric Use Norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets have not been studied in postmenopausal women and is not indicated in this population.

8.6Hepatic Impairment The pharmacokinetics of norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets have not been studied in women 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 norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets have 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 use COCs to induce withdrawal bleeding as a test for pregnancy.

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

🧒 Pediatric Use 60 words ▾

8.4Pediatric Use Safety and efficacy of norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets have been established in women of reproductive age. Efficacy is expected to be the same in post-pubertal adolescents under the age of 18 years as for users 18 years and older. Use of this product before menarche is not indicated.

🧓 Geriatric Use 30 words ▾

8.5Geriatric Use Norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets have not been studied in postmenopausal women and is 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 norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets.

12.3Pharmacokinetics Absorption Ethinyl estradiol and norethindrone are rapidly absorbed with maximum plasma concentrations occurring within 2 hours after norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets administration (see Table 1 ). Norethindrone appears to be completely absorbed following oral administration; however, it is subject to first-pass metabolism resulting in an absolute bioavailability of approximately 65 percent. Large intersubject variability is reflected in a 3- to 5-fold variation in norethindrone bioavailability.

Ethinyl estradiol bioavailability is approximately 43 percent due to small-intestinal and hepatic first-pass metabolism. Table 1. Mean ±SD Pharmacokinetic Parameters Following Single Dose Administration of Norethindrone and Ethinyl Estradiol Tablets (chewable) 0.4 mg/0.035 mg and Ferrous Fumarate Tablets in Healthy Female Subjects Under Fasting Conditions.

Norethindrone/Ethinyl Estradiol t max (h) C max (pg/mL) AUC 0- ∞ (pg•h/mL) t 1/2 (h) Norethindrone 0.4 mg 1.24 ± 0.40 a 4210.6 ± 1628.8 a 18034.9 ± 7852.9 b 8.6 ± 3.7 b Ethinyl Estradiol 35 mcg 1.44 ± 0.33 b 131.4 ± 34.2 b 1065.8 ± 276.2 b 17.1 ± 4.4 b a n = 26 b n = 25 C max = maximum plasma concentration; t max = time to reach C max ; AUC = area under the curve; t 1/2 = elimination half- life. Food Effect : Single-dose administration of norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets with food decreased the maximum norethindrone and ethinyl estradiol concentration by 53 percent and 47 percent, respectively; the extent of norethindrone and ethinyl estradiol absorption (AUC values) was not affected by food administration.

Distribution Norethindrone is 36 percent bound to sex hormone-binding globulin (SHBG) and 61 percent bound to albumin. Ethinyl estradiol is not bound to SHBG but is highly (98.5 percent) bound to albumin. Volume of distribution of norethindrone and ethinyl estradiol ranges from 2 to 4 L/kg.

Metabolism Norethindrone undergoes extensive biotransformation, primarily via reduction, followed by sulfate and glucuronide conjugation; less than 5 percent of a norethindrone dose is excreted unchanged; greater than 50 percent and 20 to 40 percent of a dose is excreted in urine and feces, respectively. The majority of metabolites in the circulation are sulfates, with glucuronides accounting for most of the urinary metabolites. Ethinyl estradiol is also extensively metabolized, both by oxidation and by conjugation with sulfate and glucuronide.

Sulfates are the major circulating conjugates of ethinyl estradiol, and glucuronides predominate in urine. The primary oxidative metabolite is 2-hydroxy-ethinyl estradiol, which is formed by the CYP3A4 isoform of cytochrome P450. Excretion Plasma clearance values for norethindrone and ethinyl estradiol are similar (approximately

0.4L/hr/kg). Ethinyl estradiol and norethindrone are excreted in both urine and feces, primarily as metabolites. Ethinyl estradiol is excreted in urine and feces as glucuronides and sulfates, and about 28 to 43 percent undergoes enterohepatic circulation.

The mean terminal elimination half-lives of norethindrone and ethinyl estradiol following single dose administration of norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets are approximately 9 hours and 17 hours, respectively.

🧬 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 ~1 min read ▾

16. HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Norethindrone and ethinyl estradiol tablets, USP (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets are available in a 28-day regimen of blister pack (NDC 79929-005-05) as follows: 21 active tablets: white to off-white, round, flat faced beveled edge, uncoated tablets debossed with "EJ1" on one side and plain on other side (0.4 mg norethindrone USP and 0.035 mg ethinyl estradiol USP). 7 inert tablets: brown, round, flat faced beveled edge, uncoated tablets debossed with 'EJ2' on one side and plain on other side; tablets may have mottled appearance on either of the surface.

The blister packs are available in box of 3 .

16.2Storage Conditions Store at 20 º C to 25º C (68 º F to 77º F); excursions permitted to 15 º C to 30º C (59 º F to 86º F) [see USP Controlled Room Temperature]. Protect from light. Keep out of the reach of children.

16.1How Supplied Norethindrone and ethinyl estradiol tablets, USP (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets are available in a 28-day regimen of blister pack (NDC 79929-005-05) as follows: 21 active tablets: white to off-white, round, flat faced beveled edge, uncoated tablets debossed with "EJ1" on one side and plain on other side (0.4 mg norethindrone USP and 0.035 mg ethinyl estradiol USP). 7 inert tablets: brown, round, flat faced beveled edge, uncoated tablets debossed with 'EJ2' on one side and plain on other side; tablets may have mottled appearance on either of the surface.

The blister packs are available in box of 3 .

📋 Description 146 words ▾

11. DESCRIPTION Norethindrone and ethinyl estradiol tablets, USP (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets are combinational contraceptive containing the progestational compound norethindrone and the estrogenic compound ethinyl estradiol. The packaging includes 21 white to off white tablets composed of norethindrone and ethinyl estradiol followed by 7 brown ferrous fumarate (placebo) tablets.

The chemical name for norethindrone is 17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one and for ethinyl estradiol the chemical name is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol. The structural formulas are: The active white to off white (norethindrone and ethinyl estradiol tablets (chewable)) tablets contain 0.4 mg norethindrone and 0.035 mg ethinyl estradiol, and the following inactive ingredients: dibasic calcium phosphate dihydrate, lactose monohydrate, magnesium stearate, maltodextrin, povidone, sodium starch glycolate, spearmint flavor and sucralose.

The brown (ferrous fumarate tablets) tablets contain crospovidone, ferrous fumarate, microcrystalline cellulose, magnesium stearate, and pregelatinized starch (maize). The ferrous fumarate tablets do not serve any therapeutic purpose. structure

💬 Information for Patients ~2 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) ].

Norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets do not protect against HIV infection (AIDS) and other sexually transmitted diseases. Norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets are not to be used during pregnancy; if pregnancy occurs during use of norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets, 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 pills are missed [see Dosage and Administration (2.3) ] . Use a back-up or alternative method of contraception when enzyme inducers are used with norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets [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) ] . A woman who starts COCs postpartum and who has not yet had a period should use an additional method of contraception until she has taken a white to off white 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) ] . Manufactured For: Naari Pte Limited 36 Robinson Road, #13-01 City House, Singapore 068877 Issued December 2021

🍼 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 Ethinyl estradiol and norethindrone are rapidly absorbed with maximum plasma concentrations occurring within 2 hours after norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets administration (see Table 1 ). Norethindrone appears to be completely absorbed following oral administration; however, it is subject to first-pass metabolism resulting in an absolute bioavailability of approximately 65 percent. Large intersubject variability is reflected in a 3- to 5-fold variation in norethindrone bioavailability.

Ethinyl estradiol bioavailability is approximately 43 percent due to small-intestinal and hepatic first-pass metabolism. Table 1. Mean ±SD Pharmacokinetic Parameters Following Single Dose Administration of Norethindrone and Ethinyl Estradiol Tablets (chewable) 0.4 mg/0.035 mg and Ferrous Fumarate Tablets in Healthy Female Subjects Under Fasting Conditions.

Norethindrone/Ethinyl Estradiol t max (h) C max (pg/mL) AUC 0- ∞ (pg•h/mL) t 1/2 (h) Norethindrone 0.4 mg 1.24 ± 0.40 a 4210.6 ± 1628.8 a 18034.9 ± 7852.9 b 8.6 ± 3.7 b Ethinyl Estradiol 35 mcg 1.44 ± 0.33 b 131.4 ± 34.2 b 1065.8 ± 276.2 b 17.1 ± 4.4 b a n = 26 b n = 25 C max = maximum plasma concentration; t max = time to reach C max ; AUC = area under the curve; t 1/2 = elimination half- life. Food Effect : Single-dose administration of norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets with food decreased the maximum norethindrone and ethinyl estradiol concentration by 53 percent and 47 percent, respectively; the extent of norethindrone and ethinyl estradiol absorption (AUC values) was not affected by food administration.

Distribution Norethindrone is 36 percent bound to sex hormone-binding globulin (SHBG) and 61 percent bound to albumin. Ethinyl estradiol is not bound to SHBG but is highly (98.5 percent) bound to albumin. Volume of distribution of norethindrone and ethinyl estradiol ranges from 2 to 4 L/kg.

Metabolism Norethindrone undergoes extensive biotransformation, primarily via reduction, followed by sulfate and glucuronide conjugation; less than 5 percent of a norethindrone dose is excreted unchanged; greater than 50 percent and 20 to 40 percent of a dose is excreted in urine and feces, respectively. The majority of metabolites in the circulation are sulfates, with glucuronides accounting for most of the urinary metabolites. Ethinyl estradiol is also extensively metabolized, both by oxidation and by conjugation with sulfate and glucuronide.

Sulfates are the major circulating conjugates of ethinyl estradiol, and glucuronides predominate in urine. The primary oxidative metabolite is 2-hydroxy-ethinyl estradiol, which is formed by the CYP3A4 isoform of cytochrome P450. Excretion Plasma clearance values for norethindrone and ethinyl estradiol are similar (approximately

0.4L/hr/kg). Ethinyl estradiol and norethindrone are excreted in both urine and feces, primarily as metabolites. Ethinyl estradiol is excreted in urine and feces as glucuronides and sulfates, and about 28 to 43 percent undergoes enterohepatic circulation.

The mean terminal elimination half-lives of norethindrone and ethinyl estradiol following single dose administration of norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets are approximately 9 hours and 17 hours, respectively.

🧬 Pharmacodynamics 22 words ▾

12.2Pharmacodynamics No specific pharmacodynamic studies were conducted with norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets.

🔬 Clinical Studies 171 words ▾

14. CLINICAL STUDIES The data presented in Section 14 are from a clinical trial conducted with norethindrone 0.4 mg/ethinyl estradiol 35 mcg tablets. Norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets are bioequivalent to these norethindrone acetate/ethinyl estradiol tablets.

In a multicenter open-label clinical trial, 1,970 women, 98% of whom were 16 to 39 years of age, were studied for up to 31 cycles (28 days per cycle) to assess the efficacy of norethindrone /ethinyl estradiol tablets, completing the equivalent of 20,230 cycles of exposure. The racial demographic of all enrolled women was: Caucasian (56%), African-American (14%), and Other (30%) (Hispanic, Native American, etc.). Of treated women, 10% were lost to follow-up, 11% discontinued related to cycle control and 7% discontinued due to other adverse events The pregnancy rate (Pearl Index [PI]) in all 1,970 women was 1.48 pregnancies per 100 women-years of use (95% confidence interval 0.94 to 2.22), based on 23 pregnancies that occurred after the onset of treatment of norethindrone /ethinyl estradiol tablets.

🧪 Nonclinical Toxicology 21 words ▾

13. NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility [See Warnings and Precautions (5.10) and Use in Specific Populations (8.1) .]

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 18 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility [See Warnings and Precautions (5.10) and Use in Specific Populations (8.1) .]

📄 Patient Package Insert ~3 min read ▾

Patient Information Norethindrone and Ethinyl Estradiol Tablets (Chewable) and Ferrous Fumarate Tablets [nawr -eth -in-deohn and e -thahyn- l es-truh -dahy- awl and fer -uh s fyoo- muh-reyt] What is the most important information I should know about norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets? Do not use norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from birth control pills, including death from heart attack, blood clots or stroke.

This risk increases with age and the number of cigarettes you smoke. What are norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets? Norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets are birth control pills (oral contraceptive) used by women to prevent pregnancy.

How does norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets 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 one clinical study of a 28-day regimen of norethindrone 0.4 mg/ethinyl estradiol 35 mcg tablets, about 1 to 2 out of 100 women may get pregnant during the first year they use norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets. 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 norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets?

Do not take norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets 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 Take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.

This may increase levels of the liver enzyme “alanine aminotransferase” (ALT) in the blood If any of these conditions happen while you are taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets, stop taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets.

What should I tell my healthcare provider before taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets ? Tell your healthcare provider if you: are pregnant or think you may be pregnant are depressed… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

Instructions For Use Important Information about taking Take 1 pill every day at the same time. Take the pills in the order directed on your blister pack. The norethindrone and ethinyl estradiol tablets, USP may be swallowed whole or chewed.

If Norethindrone and ethinyl estradiol tablets, USP are chewed, the patient should drink a full glass (8 ounces) of liquid immediately after swallowing. 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 norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets, talk to your healthcare provider. When you first start taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets, 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 norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets. 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 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 norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets 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 norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets. 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 norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets 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 norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets: 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 norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets ?

If you start taking norethindrone and ethinyl estradiol tablets (chewable) 0.4 mg/0.035 mg and ferrous fumarate tablets 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 hea… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 4 words ▾

Principal Display Panel pack

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 Norethindrone and ethinyl estradiol and ferrous fumarate (this brand).

Top reported reactions

Ear Infection2
Metrorrhagia2
Rash2
Abdominal Discomfort1
Activated Partial Thromboplastin Time Abnormal1
Antibody Test Abnormal1
Asthenopia1

Age at onset

Adult1

Reporter sex

10 reports
Female · 100%

Serious outcomes

Hospitalization2
Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product Kit / multi-component package

Kit / multi-component package

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

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
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“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

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
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 Naari Pte Limited. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Naari Pte Limited 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.
← 79929-0004-07 · Naari 79929-0006-07 · Naari →
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.