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Norethindrone Acetate 5 mg Tablet, 500-count — NDC 68462-0304-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Norethindrone Acetate 5 mg Tablet, 500-count — NDC 68462-304-05 (Billing 68462-0304-05)

by Glenmark Pharmaceuticals Inc., USA · 500 TABLET in 1 BOTTLE

This is a package of 500 tablets of Norethindrone Acetate 5 mg Tablet from Glenmark Pharmaceuticals Inc., USA, marketed since Jul 2010 and currently FDA-listed.

NDC 68462-0304-05
🏷️ FDA NDC (as labeled) 68462-304-05 billing pads the product segment with a zero
This package
Contains500-count Pack sizes2 compare ↓
Also priced by: Part D plans $0.4972/unit — full pricing hub ↓
Product page 68462-0304-50 Also comes in: 50 tablets 68462-304-50
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68462-304-05
Product NDC 68462-304
11-digit billing NDC 68462030405
RxCUI 1000405
UNII 9S44LIC7OJ
UPC 0368462304501
Application # ANDA091090
SPL Set ID d0a94321-eb60-4aa6-a429-f0156f9f8e01
Established class (EPC) Progestin
Chemical class Progesterone Congeners
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2010-07-21
Route ORAL
Dosage form TABLET
Substance NORETHINDRONE ACETATE
TE code (Orange Book) AB · RLD · RS

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

GPI-14 26000030100305
GPI class Norethindrone Acetate
GCN Seq No 003274
GCN 11280
HICL code 001443
Ingredient (HICL) Norethindrone Acetate
HIC1 code G
Therapeutic class — broad (HIC1) Female Genital System
HIC2 code G2
Therapeutic class — intermediate (HIC2) Progestogens
HIC3 code G2A
Therapeutic class — specific (HIC3) Progestational Agents
AHFS code 68:32.00.00
AHFS class Progestins
FDB label name NORETHINDRONE 5 MG TABLET
FDB brand name Norethindrone Acetate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 003274
  • GCN: 11280
  • GPI-14 (Medi-Span): 26000030100305
  • HICL (First Databank): 001443
  • AHFS class code: 68:32.00.00
  • RxCUI (RxNorm): 1000405
Why two NDCs? The FDA registers this code as 68462-304-05 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 68462-0304-05. 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, Progestogens, Estren derivatives
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 NORETHINDRONE 5 MG TABLET Ingredient Norethindrone Acetate
📖 What it is MedlinePlus · NLM

Norethindrone is used to treat endometriosis (a condition in which the type of tissue that lines the uterus [womb] grows in other areas of the body and causes pain, heavy or irregular menstruation [periods], and other symptoms). Norethindrone is also used to treat abnormal periods or bleeding and to bring on a normal menstrual cycle in women who menstruated normally in the past but have not menstruated for at least 3 months and who are not pregnant or experiencing menopause (change of life; the end of monthly menstrual periods). Norethindrone is in a class of medications called progestins. It...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Most norethindrone products, like Errin, Camila and Emzahh, are progestin-only birth control pills that prevent pregnancy. Norethindrone acetate tablets, such as Gallifrey, are use...
  • Take one tablet by mouth every day at the same time. Don't take a break between packs. Following the schedule exactly gives you the best protection, so follow your label and the pa...
  • Changes in your bleeding are the most common, including irregular or frequent bleeding. Some people get headache, breast tenderness, nausea or dizziness. Call me or your doctor if...
  • It's best not to. Smoking greatly raises the risk of heart attack and stroke in women using oral contraceptives. If you smoke, let's talk about options and quitting.
📖 Read our full Norethindrone guide →

Supplement & herbal interactions

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

Pricing

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

Price systemPer 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 · Q2 2026 $0.4972 $248.60 / 500 tablets
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 Per unit Per pack Marketing startMarketing endStatus
68462-0304-05 You're viewing this 500 TABLET in 1 BOTTLE — — 2010-07-21 — Active
68462-0304-50 68462-304-50 Main listing 50 TABLET in 1 BOTTLE $0.2898 / ea $14.49 2010-07-21 — Active

You're viewing the largest of 2 pack sizes for this product.

This pack shows little to no recent Medicaid volume — the 50 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 500-count package — 500 tablet in 1 bottle.
How does this package differ from NDC 68462-0304-50?
Both are Norethindrone Acetate 5 mg Tablet — the drug itself is identical. This page's package is the 500-count one, while NDC 68462-0304-50 is the 50 tablets package.
What NDC number is used to bill for this package of Norethindrone Acetate 5 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Norethindrone Acetate 5 mg 00555-0211-10 Teva 50 tablets $0.290 AB Availability likely —
Norethindrone acetate 5 mg 50742-0267-50 Ingenus 50 tablets $0.290 AB Availability likely —
Norethindrone Acetate 5 mg 60687-0921-21 American 30 tablets $0.290 AB Availability likely —
Gallifrey 5 mg 70700-0326-50 Xiromed 50 tablets $0.290 AB Availability likely —
Norethindrone Acetate 5 mg 42291-0650-90 AvKARE 90 tablets — AB FDA listed —
Norethindrone Acetate 5 mg 51407-0599-50 Golden 50 tablets — AB FDA listed —
Norethindrone Acetate 5 mg 65162-0475-03 Amneal 30 tablets — AB FDA listed —
Norethindrone Acetate 5 mgthis 68462-0304-05 Glenmark 500 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2010
On the market since
Jul 2010
📍
2026
Currently FDA-listed
16 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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

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

What it looks like

Color White
ShapeOval
ImprintG;304
Size11 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

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

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.

5 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerGlenmark Pharmaceuticals Inc., USA
Application holderGLENMARK PHARMACEUTICALS LTD
FDA applicationANDA091090 (ANDA)
Labeler code68462
First marketedJul 2010
Product typeHuman Prescription Drug
Portfolio343 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug / Laboratory Test Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 56 words ▾

INDICATIONS AND USAGE Norethindrone acetate is indicated for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer. Norethindrone acetate is not intended, recommended or approved to be used with concomitant estrogen therapy in postmenopausal women for endometrial protection.

⏱️ Dosage and Administration 159 words ▾

DOSAGE AND ADMINISTRATION Therapy with norethindrone acetate must be adapted to the specific indications and therapeutic response of the individual patient. Secondary amenorrhea, abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology: 2.5 to 10 mg norethindrone acetate may be given daily for 5 to 10 days to produce secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing norethindrone acetate therapy.

Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with norethindrone acetate. Endometriosis: Initial daily dosage of 5 mg norethindrone acetate for two weeks. Dosage should be increased by 2.5 mg per day every two weeks until 15 mg per day of norethindrone acetate is reached.

Therapy may be held at this level for six to nine months or until annoying breakthrough bleeding demands temporary termination.

⛔ Contraindications 82 words ▾

CONTRAINDICATIONS • Known or suspected pregnancy. There is no indication for norethindrone acetate in pregnancy. (See PRECAUTIONS ). • Undiagnosed vaginal bleeding • Known, suspected or history of cancer of the breast • Active deep vein thrombosis, pulmonary embolism or history of these conditions • Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction) • Impaired liver function or liver disease • As a diagnostic test for pregnancy • Hypersensitivity to any of the drug components

⚠️ Warnings 82 words ▾

WARNINGS 1. Cardiovascular disorders Patients with risk factors for arterial vascular disease (e.g., hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (e.g., personal history or family history of VTE, obesity, and systemic lupus erythematosus) should be managed appropriately. 2.

Visual abnormalities Discontinue medication pending examination if there is a sudden partial or complete loss of vision or if there is sudden onset of proptosis, diplopia, or migraine. If examination reveals papilledema or retinal vascular lesions, medication should be discontinued.

🤒 Adverse Reactions 132 words ▾

ADVERSE REACTIONS See WARNINGS and PRECAUTIONS . The following adverse reactions have been observed in women taking progestins: • Breakthrough bleeding • Spotting • Change in menstrual flow • Amenorrhea • Edema • Changes in weight (decreases, increases) • Changes in the cervical squamo-columnar junction and cervical secretions • Cholestatic jaundice • Rash (allergic) with and without pruritus • Melasma or chloasma • Clinical depression • Acne • Breast enlargement/tenderness • Headache/migraine • Urticaria • Abnormalities of liver tests (i.e., AST, ALT, Bilirubin) • Decreased HDL cholesterol and increased LDL/HDL ratio • Mood swings • Nausea • Insomnia • Anaphylactic/anaphylactoid reactions • Thrombotic and thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, retinal vascular thrombosis, cerebral thrombosis and embolism) • Optic neuritis (which may lead to partial or complete loss of vision)

🔄 Drug / Laboratory Test Interactions 217 words ▾

3. Drug/Laboratory Tests Interactions The following laboratory test results may be altered by the use of estrogen/progestin combination drugs: • Accelerated prothrombin time, partial thromboplastin time, and platelet aggregation time; increased platelet count; increased factors II, VII antigen, VIII antigen, VIII coagulant activity, IX, X, XII, VII-X complex, II-VII-X complex, and beta-thromboglobulin; decreased levels of antifactor X a and antithrombin III, decreased antithrombin III activity; increased levels of fibrinogen and fibrinogen activity; increased plasminogen antigen and activity. • Increased thyroid-binding globulin (TBG) levels leading to increased circulating total thyroid hormone levels as measured by protein-bound iodine (PBI), T 4 levels (by column or by radioimmunoassay) or T 3 levels by radio immunoassay.

T 3 resin uptake is decreased, reflecting the elevated TBG. Free T 4 and free T 3 concentrations are unaltered. Patients on thyroid replacement therapy may require higher doses of thyroid hormone. • Other binding proteins may be elevated in serum (i.e., corticosteroid binding globulin (CBG), sex hormone binding globulin (SHBG)) leading to increased circulating corticosteroid and sex steroids, respectively.

Free or biologically active hormone concentrations are unchanged. Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-1-antitrypsin, ceruloplasmin). • Increased plasma HDL and HDL 2 cholesterol subfraction concentrations, reduced LDL cholesterol concentration, increased triglycerides levels. • Impaired glucose metabolism. • Reduced response to metyrapone test.

🤰 Pregnancy 59 words ▾

5. Pregnancy Category X Norethindrone acetate is contraindicated during pregnancy as it may cause fetal harm when administered to pregnant women. Several reports suggest an association between intrauterine exposure to progestational drugs in the first trimester of pregnancy and congenital abnormalities in male and female fetuses. Some progestational drugs induce mild virilization of the external genitalia of female fetuses.

🧒 Pediatric Use 11 words ▾

7. Pediatric Use Norethindrone acetate tablets are not indicated in children.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY Norethindrone acetate induces secretory changes in an estrogen-primed endometrium. On a weight basis, it is twice as potent as norethindrone. PHARMACOKINETICS Absorption: Norethindrone acetate is completely and rapidly deacetylated to norethindrone (NET) after oral administration, and the disposition of norethindrone acetate is indistinguishable from that of orally administered norethindrone.

Norethindrone acetate is rapidly absorbed from norethindrone acetate tablets, with maximum plasma concentration of norethindrone generally occurring at about 2 hours post-dose. The pharmacokinetic parameters of norethindrone following single oral administration of norethindrone acetate in 29 healthy female volunteers are summarized in Table 1. Table 1 Pharmacokinetic Parameters after a Single Dose of Norethindrone Acetate in Healthy Women Norethindrone Acetate (n=29) Arithmetic Mean ± SD Norethindrone (NET) AUC (0-inf) (ng/ml*h) 166.90 ±

56.28C max (ng/ml) 26.19 ± 6.19 t max (h) 1.83 ± 0.58 t 1/2 (h) 8.51 ±

2.19AUC = area under the curve, C max = maximum plasma concentration, t max = time at maximum plasma concentration, t 1/2 = half-life, SD = standard deviation Figure 1. Mean Plasma Concentration Profile after a Single Dose of 5 mg Administered to 29 Healthy Female Volunteers under Fasting Conditions figure1 Effect of Food: The effect of food administration on the pharmacokinetics of norethindrone acetate has not been studied. Distribution: Norethindrone is 36% bound to sex hormone-binding globulin (SHBG) and 61% bound to albumin.

Volume of distribution of norethindrone is about 4 L/kg. Metabolism: Norethindrone undergoes extensive biotransformation, primarily via reduction, followed by sulfate and glucuronide conjugation. The majority of metabolites in the circulation are sulfates, with glucuronides accounting for most of the urinary metabolites.

Excretion: Plasma clearance value for norethindrone is approximately

0.4L/hr/kg. Norethindrone is excreted in both urine and feces, primarily as metabolites. The mean terminal elimination half-life of norethindrone following a single dose administration of norethindrone acetate is approximately 9 hours.

SPECIAL POPULATIONS Geriatrics The effect of age on the pharmacokinetics of norethindrone after norethindrone acetate administration has not been evaluated. Race The effect of race on the disposition of norethindrone after norethindrone acetate administration has not been evaluated. Renal Insufficiency The effect of renal disease on the disposition of norethindrone after norethindrone acetate administration has not been evaluated.

In pre-menopausal women with chronic renal failure undergoing peritoneal dialysis who received multiple doses of an oral contraceptive containing ethinyl estradiol and norethindrone, plasma norethindrone concentration was unchanged compared to concentrations in pre-menopausal women with normal renal function. Hepatic Insufficiency The effect of hepatic disease on the disposition of norethindrone after norethindrone acetate administration has not been evaluated. However, norethindrone acetate is contraindicated in markedly impaired liver function or liver disease.

Drug Interactions No pharmacokinetic drug interaction studies investigating any drug-drug interactions with norethindrone acetate have been conducted.

📦 How Supplied / Storage and Handling 47 words ▾

HOW SUPPLIED Norethindrone acetate tablets USP are available as: 5 mg: White to off-white oval, flat faced beveled edged, uncoated tablets debossed with ‘G with breakline’ on one side and 304 on other side. Available as follows: Bottles of 50 NDC 68462-304-50 Bottles of 500 NDC 68462-304-05

📦 Storage and Handling 30 words ▾

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Distributed by: Glenmark Pharmaceuticals Inc., USA Elmwood Park, NJ 07407 Questions? 1 (888)721-7115 www.glenmarkpharma-us.com August 2025 glenmarklogo1

📋 Description 59 words ▾

DESCRIPTION Norethindrone acetate tablets USP - 5 mg oral tablets. Norethindrone acetate USP, (17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one acetate), a synthetic, orally active progestin, is the acetic acid ester of norethindrone. It is a white, or creamy white, crystalline powder.

Norethindrone acetate tablets USP, 5 mg contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and talc. structure

💬 Information for Patients 23 words ▾

2. Information for the Patient Healthcare providers are advised to discuss the PATIENT INFORMATION leaflet with patients for whom they prescribe norethindrone acetate.

⚠️ Precautions ~3 min read ▾

PRECAUTIONS 1. General Precautions • Because this drug may cause some degree of fluid retention, conditions which might be influenced by this factor, such as epilepsy, migraine, cardiac or renal dysfunctions, require careful observation • In cases of breakthrough bleeding, and in all cases of irregular bleeding per vagina, nonfunctional causes should be borne in mind. In cases of undiagnosed vaginal bleeding, adequate diagnostic measures are indicated • Patients who have a history of clinical depression should be carefully observed and the drug discontinued if the depression recurs to a serious degree • Data suggest that progestin therapy may have adverse effects on lipid and carbohydrate metabolism.

The choice of progestin, its dose, and its regimen may be important in minimizing these adverse effects, but these issues will require further study before they are clarified. Women with hyperlipidemias and/or diabetes should be monitored closely during progestin therapy • The pathologist should be advised of progestin therapy when relevant specimens are submitted 2. Information for the Patient Healthcare providers are advised to discuss the PATIENT INFORMATION leaflet with patients for whom they prescribe norethindrone acetate.

3. Drug/Laboratory Tests Interactions The following laboratory test results may be altered by the use of estrogen/progestin combination drugs: • Accelerated prothrombin time, partial thromboplastin time, and platelet aggregation time; increased platelet count; increased factors II, VII antigen, VIII antigen, VIII coagulant activity, IX, X, XII, VII-X complex, II-VII-X complex, and beta-thromboglobulin; decreased levels of antifactor X a and antithrombin III, decreased antithrombin III activity; increased levels of fibrinogen and fibrinogen activity; increased plasminogen antigen and activity. • Increased thyroid-binding globulin (TBG) levels leading to increased circulating total thyroid hormone levels as measured by protein-bound iodine (PBI), T 4 levels (by column or by radioimmunoassay) or T 3 levels by radio immunoassay.

T 3 resin uptake is decreased, reflecting the elevated TBG. Free T 4 and free T 3 concentrations are unaltered. Patients on thyroid replacement therapy may require higher doses of thyroid hormone. • Other binding proteins may be elevated in serum (i.e., corticosteroid binding globulin (CBG), sex hormone binding globulin (SHBG)) leading to increased circulating corticosteroid and sex steroids, respectively.

Free or biologically active hormone concentrations are unchanged. Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-1-antitrypsin, ceruloplasmin). • Increased plasma HDL and HDL 2 cholesterol subfraction concentrations, reduced LDL cholesterol concentration, increased triglycerides levels. • Impaired glucose metabolism. • Reduced response to metyrapone test. 4.

Carcinogenesis, Mutagenesis, and Impairment of Fertility Some beagle dogs treated with medroxyprogesterone acetate developed mammary nodules. Although nodules occasionally appeared in control animals, they were intermittent in nature, whereas nodules in treated animals were larger and more numerous, and persisted. There is no general agreement as to whether the nodules are benign or malignant.

Their significance with respect to humans has not been established. 5. Pregnancy Category X Norethindrone acetate is contraindicated during pregnancy as it may cause fetal harm when administered to pregnant women.

Several reports suggest an association between intrauterine exposure to progestational drugs in the first trimester of pregnancy and congenital abnormalities in male and female fetuses. Some progestational drugs induce mild virilization of the external genitalia of female fetuses. 6.

Nursing Mothers Detectable amounts of progestins have been identified in the milk of mothers receiving them. Caution should be exercised when progestins are administered to a nursing woman. 7.

Pediatric Use Norethindron… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 29 words ▾

6. Nursing Mothers Detectable amounts of progestins have been identified in the milk of mothers receiving them. Caution should be exercised when progestins are administered to a nursing woman.

🧬 Pharmacokinetics ~2 min read ▾

PHARMACOKINETICS Absorption: Norethindrone acetate is completely and rapidly deacetylated to norethindrone (NET) after oral administration, and the disposition of norethindrone acetate is indistinguishable from that of orally administered norethindrone. Norethindrone acetate is rapidly absorbed from norethindrone acetate tablets, with maximum plasma concentration of norethindrone generally occurring at about 2 hours post-dose. The pharmacokinetic parameters of norethindrone following single oral administration of norethindrone acetate in 29 healthy female volunteers are summarized in Table 1.

Table 1 Pharmacokinetic Parameters after a Single Dose of Norethindrone Acetate in Healthy Women Norethindrone Acetate (n=29) Arithmetic Mean ± SD Norethindrone (NET) AUC (0-inf) (ng/ml*h) 166.90 ±

56.28C max (ng/ml) 26.19 ± 6.19 t max (h) 1.83 ± 0.58 t 1/2 (h) 8.51 ±

2.19AUC = area under the curve, C max = maximum plasma concentration, t max = time at maximum plasma concentration, t 1/2 = half-life, SD = standard deviation Figure 1. Mean Plasma Concentration Profile after a Single Dose of 5 mg Administered to 29 Healthy Female Volunteers under Fasting Conditions figure1 Effect of Food: The effect of food administration on the pharmacokinetics of norethindrone acetate has not been studied. Distribution: Norethindrone is 36% bound to sex hormone-binding globulin (SHBG) and 61% bound to albumin.

Volume of distribution of norethindrone is about 4 L/kg. Metabolism: Norethindrone undergoes extensive biotransformation, primarily via reduction, followed by sulfate and glucuronide conjugation. The majority of metabolites in the circulation are sulfates, with glucuronides accounting for most of the urinary metabolites.

Excretion: Plasma clearance value for norethindrone is approximately

0.4L/hr/kg. Norethindrone is excreted in both urine and feces, primarily as metabolites. The mean terminal elimination half-life of norethindrone following a single dose administration of norethindrone acetate is approximately 9 hours.

SPECIAL POPULATIONS Geriatrics The effect of age on the pharmacokinetics of norethindrone after norethindrone acetate administration has not been evaluated. Race The effect of race on the disposition of norethindrone after norethindrone acetate administration has not been evaluated. Renal Insufficiency The effect of renal disease on the disposition of norethindrone after norethindrone acetate administration has not been evaluated.

In pre-menopausal women with chronic renal failure undergoing peritoneal dialysis who received multiple doses of an oral contraceptive containing ethinyl estradiol and norethindrone, plasma norethindrone concentration was unchanged compared to concentrations in pre-menopausal women with normal renal function. Hepatic Insufficiency The effect of hepatic disease on the disposition of norethindrone after norethindrone acetate administration has not been evaluated. However, norethindrone acetate is contraindicated in markedly impaired liver function or liver disease.

Drug Interactions No pharmacokinetic drug interaction studies investigating any drug-drug interactions with norethindrone acetate have been conducted.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 65 words ▾

4. Carcinogenesis, Mutagenesis, and Impairment of Fertility Some beagle dogs treated with medroxyprogesterone acetate developed mammary nodules. Although nodules occasionally appeared in control animals, they were intermittent in nature, whereas nodules in treated animals were larger and more numerous, and persisted.

There is no general agreement as to whether the nodules are benign or malignant. Their significance with respect to humans has not been established.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION Norethindrone acetate tablets USP, 5 mg Read this PATIENT INFORMATION before you start taking norethindrone acetate tablets and read what you get each time you refill norethindrone acetate tablets. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition.

What is the most important information I should know about norethindrone acetate (A Progestin Hormone) tablets? • Do not use norethindrone acetate if you are pregnant, breastfeeding or are trying to conceive. • Do not use northindrone acetate if you have had a previous blood clot, stroke, or heart attack. • Do not use norethindrone acetate if you are postmenopausal. What is norethindrone acetate? Norethindrone acetate is similar to the progesterone hormones naturally produced by the body.

Your healthcare provider may provide norethindrone acetate as individual tablets. What are norethindrone acetate tablets used for? Norethindrone acetate tablets are used for the treatment of secondary amenorrhea (absence of menstrual periods in women who have previously had a menstrual period who are not pregnant), the treatment of endometriosis, and the treatment of irregular menstrual periods due to hormone imbalance.

Who should not take norethindrone acetate tablets? You should not take norethindrone acetate tablets if you are postmenopausal, pregnant or breastfeeding. You should not take norethindrone acetate tablets if you have the following conditions: • Known or suspected pregnancy.

Norethindrone acetate tablets are not indicated during pregnancy as it may cause fetal harm when administered to pregnant women. There is an increased risk of minor birth defects in children whose mothers take norethindrone acetate during the first 4 months of pregnancy (mild masculinization of the external genitalia of the female fetus, as well as hypospadias in the male fetus). If you take norethindrone acetate and later find out you were pregnant, talk with your healthcare provider right away • History of blood clots in the legs, lungs, eyes, brain, or elsewhere, or a past history of these conditions • Liver impairment or disease • Known or suspected cancer of the breast.

If you have or had cancer of the breast, talk with your healthcare provider about whether you should take norethindrone acetate • Undiagnosed vaginal bleeding • Hypersensitivity to norethindrone acetate tablets. See the end of this leaflet for a list of all of the ingredients in norethindrone acetate What are the risks associated with norethindrone acetate tablets? • Risk to the Fetus: Norethindrone acetate tablets should not be used if you are pregnant. Norethindrone acetate tablets are contraindicated during pregnancy as it may cause fetal harm when administered to pregnant women.

There is an increased risk of minor birth defects in children whose mothers take this drug during the first 4 months of pregnancy. Several reports suggest an association between mothers who take these drugs in the first trimester of pregnancy and congenital abnormalities in male and female babies. Although it is not clear that these events were drug related, you should check with your healthcare provider about the risks to your unborn child of any medication taken during pregnancy.

You should avoid using norethindrone acetate tablets during pregnancy. If you take norethindrone acetate tablets and later find you were pregnant when you took it, be sure to discuss this with your healthcare provider as soon as possible. • Abnormal Blood Clotting: Use of progestational drugs, such as norethindrone acetate, has been associated with changes in the blood-clotting system. These changes allow the blood to clot more easily, possibly allowing clots to form in the bloodstream.

If blood clots do form in your bloodstream, they can cut off the blood supply to vital organs, causing serious problems. These problems may include a stroke (by cutting off blood to part of the br… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 16 words ▾

Principal Display Panel NDC 68462-304-50 Norethindrone Acetate Tablets USP Bottle Label 5 mg 50 tablets label5mg

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

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
50 tablets68462-0304-50 162,942 Rx · $3,879,324
500 tablets this page68462-0304-05 No Medicaid data
Drug total (last 4 qtrs): 162,942 Rx · 8,275,985 units · $3,879,324 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Norethindrone Acetate — the program that covers self-administered drugs. 4 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Norethindrone Acetate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$565.1K
Claims incl. refills
14.2K
Beneficiaries
8.9K
Spend / beneficiary
$63.32
Spend / claim
$39.71
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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 acetate — the ingredient across all brands.

Top reported reactions

Nausea905
Headache816
Fatigue658
Pain537
Therapy Interrupted512
Anxiety485
Dizziness464

Age at onset

Neonate4
Infant1
Child2
Adolescent100
Adult1,396
Elderly51

Reporter sex

13,257 reports
Male · 0%
Female · 99%
Unknown · 0%

Serious outcomes

Hospitalization1,538
Life-threatening251
Death104
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,323 402
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
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) ✓ 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
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

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 Glenmark Pharmaceuticals Inc., USA. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 50 tablets (68462-0304-50). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Glenmark Pharmaceuticals Inc., USA is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 68462-0303-29 · Glenmark 68462-0305-29 · Glenmark →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.