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Norethindrone 0.35 mg Tablet, 84-count — NDC 0378-7272-53 (Billing 00378-7272-53)

by Mylan Pharmaceuticals Inc. · 3 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 28 TABLET in 1 BLISTER PACK

This is a package of 84 tablets of Norethindrone 0.35 mg Tablet from Mylan Pharmaceuticals Inc., no longer marketed, no longer in the FDA NDC Directory; retail pharmacies pay about $0.0907 per tablet (NADAC). It is this product's only package size.

NDC 00378-7272-53
🏷️ FDA NDC (as labeled) 0378-7272-53 billing pads the labeler segment with a zero
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Mar 13, 2024 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0378-7272-53
Product NDC 0378-7272
11-digit billing NDC 00378727253
NCPDP billing unit EA — each (per item)
Application # ANDA200980
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 May 2026)
Route ORAL
Dosage form TABLET
Substance NORETHINDRONE
TE code (Orange Book) AB2 · RLD · RS

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

GCN Seq No 003313
GCN 11520
HICL code 001459
Ingredient (HICL) Norethindrone
HIC1 code G
Therapeutic class — broad (HIC1) Female Genital System
HIC2 code G8
Therapeutic class — intermediate (HIC2) Systemic Antifertility Agents
HIC3 code G8A
Therapeutic class — specific (HIC3) Contraceptives,Oral
AHFS code 68:12.00.00
AHFS class Contraceptives
FDB label name NORETHINDRONE 0.35 MG TABLET
FDB brand name Norethindrone
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 003313
  • GCN: 11520
  • HICL (First Databank): 001459
  • AHFS class code: 68:12.00.00
Why two NDCs? The FDA registers this code as 0378-7272-53 — 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 → 00378-7272-53. 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.

Clinical

Label name NORETHINDRONE 0.35 MG TABLET Ingredient Norethindrone
📖 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 →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

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

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.091 $7.62 / 84 tablets
Medicaid paysCMS SDUD · 12 mo $0.2528 $21.24 / 84 tablets
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.170 $0.085
▼ Down 46% 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00378-7272-53 You're viewing this Main listing 3 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 28 TABLET in 1 BLISTER PACK 2013-06-24 — Discontinued by firm

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Norethindrone 0.35 mgthis 00378-7272-53 Mylan 84 tablets $0.091 AB2 Discontinued —
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.

Inactive Ingredients / Excipients

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

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerMylan Pharmaceuticals Inc.
Application holderXIROMED LLC
FDA applicationANDA200980 (ANDA)
Labeler code00378
Product typeHuman Prescription Drug
Portfolio473 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. 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.

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
134.9K
Units reimbursed last 4 qtrs
6.9M
Gross reimbursed last 4 qtrs
$1.76M
Avg / prescription
$13.02
Avg / unit
$0.2528
Latest quarter Q4 2025
4.2KRx
Medicaid pays / ea
$0.2528
gross reimbursed
vs
NADAC / ea
$0.0907
acquisition cost
=
Spread
+$0.1621
+179% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
43% FFS 57% MCO
Fee-for-service · 57,570 Rx Managed care · 77,303 Rx
State Medicaid map
Alaska: 6,300 units · 859 per 100k residents AK Maine: 71,400 units · 5,118 per 100k residents ME Washington: 26,668 units · 341 per 100k residents WA Idaho: 42,168 units · 2,147 per 100k residents ID Montana: 23,912 units · 2,112 per 100k residents MT North Dakota: 4,060 units · 519 per 100k residents ND Minnesota: 268,688 units · 4,683 per 100k residents MN Wisconsin: 299,574 units · 5,069 per 100k residents WI Michigan: 291,548 units · 2,905 per 100k residents MI New York: 1,047,481 units · 5,352 per 100k residents NY Vermont: 32,116 units · 4,964 per 100k residents VT New Hampshire: 30,436 units · 2,171 per 100k residents NH Oregon: 111,724 units · 2,639 per 100k residents OR Nevada: 42,588 units · 1,333 per 100k residents NV Wyoming: 7,392 units · 1,266 per 100k residents WY South Dakota: 8,708 units · 948 per 100k residents SD Iowa: 73,220 units · 2,283 per 100k residents IA Illinois: 436,872 units · 3,481 per 100k residents IL Indiana: 60,088 units · 876 per 100k residents IN Ohio: 207,464 units · 1,760 per 100k residents OH Pennsylvania: 196,672 units · 1,517 per 100k residents PA New Jersey: 266,949 units · 2,874 per 100k residents NJ Massachusetts: 117,992 units · 1,685 per 100k residents MA California: 243,764 units · 626 per 100k residents CA Utah: 24,080 units · 705 per 100k residents UT Colorado: 187,124 units · 3,183 per 100k residents CO Nebraska: 57,988 units · 2,932 per 100k residents NE Missouri: 178,808 units · 2,886 per 100k residents MO Kentucky: 144,592 units · 3,195 per 100k residents KY West Virginia: 56,868 units · 3,213 per 100k residents WV Virginia: 75,824 units · 870 per 100k residents VA Maryland: 141,256 units · 2,286 per 100k residents MD Connecticut: 137,594 units · 3,804 per 100k residents CT Rhode Island: 47,432 units · 4,332 per 100k residents RI Arizona: 143,304 units · 1,928 per 100k residents AZ New Mexico: 126,980 units · 6,007 per 100k residents NM Kansas: 25,704 units · 874 per 100k residents KS Arkansas: 26,796 units · 874 per 100k residents AR Tennessee: 230,478 units · 3,234 per 100k residents TN North Carolina: 345,466 units · 3,188 per 100k residents NC South Carolina: 42,364 units · 788 per 100k residents SC Delaware: 31,584 units · 3,063 per 100k residents DE Oklahoma: 126,700 units · 3,126 per 100k residents OK Louisiana: 226,576 units · 4,954 per 100k residents LA Mississippi: 53,262 units · 1,812 per 100k residents MS Alabama: 65,100 units · 1,274 per 100k residents AL Georgia: 40,416 units · 366 per 100k residents GA D.C.: 7,952 units · 1,171 per 100k residents DC Hawaii: 11,872 units · 827 per 100k residents HI Texas: 362,642 units · 1,189 per 100k residents TX Florida: 112,120 units · 496 per 100k residents FL
Units reimbursed · per 100k residents
3416,007
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New Mexico 6,007 /100k
2 New York 5,352 /100k
3 Maine 5,118 /100k
4 Wisconsin 5,069 /100k
5 Vermont 4,964 /100k
6 Louisiana 4,954 /100k
7 Minnesota 4,683 /100k
8 Rhode Island 4,332 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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

Medicare Part D (outpatient prescription) spending for Norethindrone — the program that covers self-administered drugs. 3 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. 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
$173.4K
Claims incl. refills
10.6K
Beneficiaries
6.4K
Spend / beneficiary
$26.90
Spend / claim
$16.38
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.

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) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Who lists this product with the FDA?
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.
← 00378-7187-05 · Mylan 00378-7274-53 · Mylan →
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.