Prescription drug · ANDA
Norethindrone Acetate (Norethindrone) NDC 65162-475
Norethindrone acetate 5 mg/1 · Tablet · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-475-03 | 65162047503 | 30 TABLET in 1 BOTTLE (65162-475-03)Marketed from Jul 1, 2009 | |
| 65162-475-05 | 65162047505 | 50 TABLET in 1 BOTTLE (65162-475-05)Marketed from Jul 1, 2009 | |
| 65162-475-09 | 65162047509 | 90 TABLET in 1 BOTTLE (65162-475-09)Marketed from Jul 1, 2009 | |
| 65162-475-50 | 65162047550 | 500 TABLET in 1 BOTTLE (65162-475-50)Marketed from Jul 1, 2009 |
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
- Active ingredients
- Norethindrone acetate — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 65162
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200275
- Marketing start
- Listing expires
- Other FDA classes
- Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 65162-475_764f6075-288a-4435-b148-35589e5e5835SPL ID 764f6075-288a-4435-b148-35589e5e5835SPL set ID 64cb920c-36e8-4d62-9d08-3ddf3989d313RxCUI 1000405UNII 9S44LIC7OJUPC 0365162475098
- 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
N465162047503followed by a unit qualifier and the quantityPackage 65162-0475-03. 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 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 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 65162-475
- What is NDC 65162-475?
- 65162-475 is the product NDC for Norethindrone Acetate (norethindrone), Norethindrone acetate 5 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Norethindrone Acetate (Norethindrone).
- What is the active ingredient?
- Norethindrone acetate.
- Who is the labeler?
- Amneal Pharmaceuticals LLC, NDC labeler code 65162. 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 Acetate | Norethindrone acetate 5 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0555-0211 | 00555-0211-10 |
| Norethindrone Acetate | Norethindrone acetate 5 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-599 | 51407-0599-50 |
Other NDCs under ANDA 200275
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 Acetatenorethindrone | Norethindrone acetate 5 mg/1 | TabletOral | AvKARE | 42291-650 |