NDC 00378-7291-89 — Norethindrone Acetate 5 mg Tablet, 50-count

🆔 Identity & classification

FDA NDC (as labeled) 0378-7291-89

Product NDC 0378-7291

11-digit billing NDC 00378729189

NCPDP billing unit EA — each (per item)

Application # ANDA205278

Established class (EPC) Progesterone Congeners [CS], Progestin

DEA schedule Non-controlled

Marketing category ANDA

Marketing status Discontinued

FDA listing status Discontinued by firm (certified through Nov 2025)

Route ORAL

Dosage form TABLET

Substance 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

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 0378-7291-89 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00378-7291-89. 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.

🏭 Manufacturer & labeler

LabelerMylan Pharmaceuticals Inc.

Application holderXIROMED LLC

FDA applicationANDA205278 (ANDA)

Labeler code00378

Product typeHuman Prescription Drug

Portfolio473 products on file

🔎 All NDCs from Mylan Pharmaceuticals Inc.

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.

🩺 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

It depends on the product. Most norethindrone tablets — including brands like Camila, Errin, Emzahh, and Affodel — are progestin-only birth control pills taken daily to prevent pre...
Regular combination birth control pills contain two hormones — estrogen and progestin. Norethindrone is a progestin-only pill, sometimes called the 'mini-pill.' Because it has no e...
How is this different from regular birth control pills?
The most common thing people notice is irregular bleeding — spotting between periods, or changes in your cycle. Headache, breast tenderness, nausea, and dizziness are also reported...

📖 Read our full Norethindrone guide →

Patient education

📘 MedlinePlus patient leaflet ↗

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.

🧪 Inactive Ingredients / Excipients

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

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

Where does this data come from?

Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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 system	Per ea	Per package
Retail pharmacies payNADAC · weekly	$0.295	$14.74 / 50 tablets
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

NADAC price history (per ea) — tap or hover for the price & month

▼ Down 48% over the last 24 months.

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Norethindrone Acetate 5 mg 00555-0211-10	Teva	50 tablets	$0.295	AB	Availability likely	—
Norethindrone acetate 5 mg 50742-0267-50	Ingenus	50 tablets	$0.295	AB	Availability likely	—
Norethindrone Acetate 5 mg 60687-0921-21	American	30 tablets	$0.295	AB	Availability likely	—
Gallifrey 5 mg 70700-0326-50	Xiromed	50 tablets	$0.295	AB	Availability likely	—
Norethindrone Acetate 5 mgthis 00378-7291-89	Mylan	50 tablets	$0.295	AB	Discontinued	—
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 mg 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

📍

2026

Currently FDA-listed

listed with the FDA

🔓

·

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.

📊 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.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
00378-7291-89 You're viewing this	50 TABLET in 1 BOTTLE (0378-7291-89)	2019-07-19	Discontinued by firm

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)

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)	— Not published for this NDC No structured label is linked to this listing in DailyMed/openFDA.
Package photos	— Not published for this NDC The FDA label for this product carries no photos.
Inactive ingredients (structured)	— Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS)	✓ Available
Orange Book / therapeutic-equivalence data	✓ Available
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— 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 full label on this page?

No structured FDA label (SPL) is currently linked to this NDC in DailyMed/openFDA. That can happen with older listings, certain OTC and repackaged products, and recently updated listings whose label has not yet propagated. The listing itself is still valid — this page shows everything the public feeds provide for this package.

What does the discontinued status mean for this NDC?

The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 0378-7291-89, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00378-7291-89, written without dashes as 00378729189. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 00378-7291-89, the first segment (00378) is the labeler code FDA assigned to Mylan Pharmaceuticals Inc.; the middle segment (7291) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (89) identifies this exact package size and type. Together they name one specific package of one specific product.

Who lists this product with the FDA?

Mylan Pharmaceuticals Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

📄 FDA label

📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.

🔗 Related NDC lookups

🧪 All Norethindrone Acetate NDCsSame ingredient 🏭 All Mylan labeler NDCsLabeler code 00378 📚 All Progesterone Congeners [CS], Progestin NDCsDrug class

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Progestational Agents.

Medroxyprogesterone Acetate 00009-0051-01 Progesterone, Micronized 00023-6150-04 Progesterone 00143-9725-01 Hydroxyprogesterone Caproate 67457-0886-05

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.