Prescription drug · ANDA
Norethindrone Acetate NDC 51407-599
Norethindrone acetate 5 mg/1 · Tablet · Oral · Golden State Medical Supply, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51407-599-50 | 5140705995051407059950 | 50 TABLET in 1 BOTTLE (51407-599-50)Marketed from Dec 20, 2024 |
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
- Golden State Medical Supply, Inc.NDC labeler code 51407
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075951
- Marketing start
- Listing expires
- Other FDA classes
- Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 51407-599_2bb2a27e-11f5-a9fb-e063-6394a90a1ea8SPL ID 2bb2a27e-11f5-a9fb-e063-6394a90a1ea8SPL set ID 2bb29135-6e9b-a9e2-e063-6394a90ae9e4RxCUI 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
N451407059950followed by a unit qualifier and the quantityPackage 51407-0599-50. 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 Tablets, USP are 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 Tablets, USP are 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.
About NDC 51407-599
- What is NDC 51407-599?
- 51407-599 is the product NDC for Norethindrone Acetate, Norethindrone acetate 5 mg/1 tablet, listed with the FDA by Golden State Medical Supply, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Norethindrone Acetate.
- What is the active ingredient?
- Norethindrone acetate.
- Who is the labeler?
- Golden State Medical Supply, Inc., NDC labeler code 51407. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Norethindrone Acetate?
- 6 other product NDCs are listed under this name. See all Norethindrone Acetate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Norethindrone Acetate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Norethindrone Acetate | Norethindrone acetate 5 mg/1 | TabletOral | American Health Packaging | 60687-921 | 60687-0921-21 |
| Norethindrone acetate | Norethindrone acetate 5 mg/1 | TabletOral | Ingenus Pharmaceuticals, LLC | 50742-267 | 50742-0267-50 |
| Norethindrone Acetatenorethindrone | Norethindrone acetate 5 mg/1 | TabletOral | AvKARE | 42291-650 | 42291-0650-90 |
| Norethindrone Acetate | Norethindrone acetate 5 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-304 | 68462-0304-0568462-0304-50 |
| Norethindrone Acetatenorethindrone | Norethindrone acetate 5 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-475 | 65162-0475-0365162-0475-0565162-0475-09+1 more |
| Norethindrone Acetate | Norethindrone acetate 5 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0555-0211 | 00555-0211-10 |
Other NDCs under ANDA 075951
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 | Teva Pharmaceuticals USA, Inc. | 0555-0211 |