Prescription drug · ANDA
Megestrol Acetate NDC 0904-7236
Megestrol acetate 40 mg/1 · Tablet · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7236-61 | 00904723661 | 100 BLISTER PACK in 1 CARTON (0904-7236-61) / 1 TABLET in 1 BLISTER PACKMarketed from Jun 1, 2022 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Megestrol Acetate
- Generic name (nonproprietary)
- megestrol acetate
- Active ingredients
- Megestrol acetate — 40 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Major Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 072423
- Marketing start
- Listing expires
- Other FDA classes
- Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 0904-7236_daa433c7-de6b-4e37-bdd9-2687d1a825ecSPL ID daa433c7-de6b-4e37-bdd9-2687d1a825ecSPL set ID 2c755c6b-32e9-4029-8b70-855007f7375bRxCUI 860221UNII TJ2M0FR8ES
- 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
N400904723661followed by a unit qualifier and the quantityPackage 00904-7236-61. 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 Megestrol acetate tablets are indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (ie, recurrent, inoperable, or metastatic disease). It should not be used in lieu of currently accepted procedures such as surgery, radiation, or chemotherapy.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 072423
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 |
|---|---|---|---|---|
| Megestrol Acetate | Megestrol acetate 40 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-159 |
| Megestrol Acetate | Megestrol acetate 40 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2181 |