Prescription drug · ANDA
Megestrol Acetate NDC 70954-896
Megestrol acetate 40 mg/mL · Suspension · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70954-896-10 | 70954089610 | 240 mL in 1 BOTTLE (70954-896-10)Marketed from Jul 2, 2024 | |
| 70954-896-20 | 70954089620 | 480 mL in 1 BOTTLE (70954-896-20)Marketed from Jul 2, 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)
- Megestrol Acetate
- Generic name (nonproprietary)
- megestrol acetate
- Active ingredients
- Megestrol acetate — 40 mg/mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.
- 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 70954-896_a26dcd78-ad62-4cf5-ad97-49ccb34d43baSPL ID a26dcd78-ad62-4cf5-ad97-49ccb34d43baSPL set ID a26dcd78-ad62-4cf5-ad97-49ccb34d43baRxCUI 860225UNII TJ2M0FR8ESUPC 0370954896203
- 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
N470954089610followed by a unit qualifier and the quantityPackage 70954-0896-10. 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 & 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 | American Health Packaging | 60687-916 |
| Megestrol Acetate | Megestrol acetate 400 mg/10mL | SuspensionOral | Major Pharmaceuticals | 0904-7577 |
| Megestrol Acetate | Megestrol acetate 400 mg/10mL | SuspensionOral | PAI Holdings, LLC dba PAI Pharma | 0121-1038 |