Prescription drug · ANDA
Norethindrone acetate NDC 50742-267
Norethindrone acetate 5 mg/1 · Tablet · Oral · Ingenus Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50742-267-50 | 50742026750 | 50 TABLET in 1 BOTTLE (50742-267-50)Marketed from Aug 29, 2019 |
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
- Ingenus Pharmaceuticals, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206490
- Marketing start
- Listing expires
- Other FDA classes
- Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 50742-267_ec08066e-8299-493e-b502-e56db778b15eSPL ID ec08066e-8299-493e-b502-e56db778b15eSPL set ID 2f39b608-cc62-4ff0-a52a-bc3343275269RxCUI 1000405UNII 9S44LIC7OJUPC 0350742267507
- 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
N450742026750followed by a unit qualifier and the quantityPackage 50742-0267-50. 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 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 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.