Prescription drug · ANDA
Norethindrone Acetate NDC 60687-921
Norethindrone acetate 5 mg/1 · Tablet · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60687-921-21 | 60687092121 | 30 BLISTER PACK in 1 CARTON (60687-921-21) / 1 TABLET in 1 BLISTER PACK (60687-921-11)Marketed from Jan 14, 2026 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Norethindrone Acetate
- Generic name (nonproprietary)
- norethindrone acetate
- Active ingredients
- Norethindrone acetate — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- American Health Packaging
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091090
- Marketing start
- Listing expires
- Other FDA classes
- Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 60687-921_485ceb49-adae-1b29-e063-6294a90aded8SPL ID 485ceb49-adae-1b29-e063-6294a90aded8SPL set ID eb0b80e0-5b69-4efa-ae8a-62e718a62dc3RxCUI 1000405UNII 9S44LIC7OJ
- Pharmacologic class
- Progestin
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N460687092121followed by a unit qualifier and the quantityPackage 60687-0921-21. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
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.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091090
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Norethindrone Acetate | Norethindrone acetate 5 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-304 |