Prescription drug · ANDA
Megestrol Acetate NDC 0904-7577
Megestrol acetate 400 mg/10mL · Suspension · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7577-18 | 00904757718 | 4 TRAY in 1 CASE (0904-7577-18) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0904-7577-66)Marketed from Jan 15, 2026 | |
| 0904-7577-72 | 00904757772 | 10 TRAY in 1 CASE (0904-7577-72) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0904-7577-66)Marketed from Dec 29, 2025 |
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 — 400 mg/10mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Major Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077404
- Marketing start
- Listing expires
- Other FDA classes
- Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 0904-7577_1843fe79-7628-4f8e-9b51-e0be7562e43dSPL ID 1843fe79-7628-4f8e-9b51-e0be7562e43dSPL set ID e44cf173-991b-43cf-93f2-e0efaa4cc29aRxCUI 860225UNII TJ2M0FR8ESUPC 0309047577668
- 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
N400904757718followed by a unit qualifier and the quantityPackage 00904-7577-18. 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 oral suspension is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS).
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077404
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/mL | SuspensionOral | ANI Pharmaceuticals, Inc. | 70954-896 |
| Megestrol Acetate | Megestrol acetate 40 mg/mL | SuspensionOral | American Health Packaging | 60687-916 |
| Megestrol Acetate | Megestrol acetate 400 mg/10mL | SuspensionOral | PAI Holdings, LLC dba PAI Pharma | 0121-1038 |