Prescription drug · ANDA
Megestrol Acetate NDC 0121-1038
Megestrol acetate 400 mg/10mL · Suspension · Oral · PAI Holdings, LLC dba PAI Pharma
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0121-1038-00 | 0012110380000121103800 | 10 TRAY in 1 CASE (0121-1038-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1038-10)Marketed from Oct 17, 2025 | |
| 0121-1038-40 | 0012110384000121103840 | 4 TRAY in 1 CASE (0121-1038-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1038-10)Marketed from Oct 17, 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
- PAI Holdings, LLC dba PAI PharmaNDC labeler code 0121
- 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 0121-1038_5dbcf915-968f-4377-b56f-8ef863e398caSPL ID 5dbcf915-968f-4377-b56f-8ef863e398caSPL set ID 2d5b58cd-cbb1-4f5c-b13f-63185c0f8e31RxCUI 860225UNII 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
N400121103800followed by a unit qualifier and the quantityPackage 00121-1038-00. 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.
About NDC 0121-1038
- What is NDC 0121-1038?
- 0121-1038 is the product NDC for Megestrol Acetate, Megestrol acetate 400 mg/10mL suspension, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Megestrol Acetate.
- What is the active ingredient?
- Megestrol acetate.
- Who is the labeler?
- PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Megestrol Acetate?
- 23 other product NDCs are listed under this name. See all Megestrol Acetate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Megestrol 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) |
|---|---|---|---|---|---|
| Megestrol Acetate | Megestrol acetate 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4640 | 70518-4640-00 |
| Megestrol Acetate | Megestrol acetate 40 mg/mL | SuspensionOral | American Health Packaging | 60687-916 | 60687-0916-0860687-0916-56 |
| Megestrol Acetate | Megestrol acetate 400 mg/10mL | SuspensionOral | Major Pharmaceuticals | 0904-7577 | 00904-7577-1800904-7577-72 |
| Megestrol Acetate | Megestrol acetate 40 mg/mL | SuspensionOral | Kesin Pharma Corporation | 81033-150 | 81033-0150-4381033-0150-4481033-0150-52 |
| Megestrol Acetate | Megestrol acetate 40 mg/mL | SuspensionOral | Xttrium Laboratories, Inc. | 0116-4011 | 00116-4011-0800116-4011-1100116-4011-16+2 more |
| Megestrol Acetate | Megestrol acetate 40 mg/mL | SuspensionOral | Preferred Pharmaceuticals Inc. | 68788-8714 | 68788-8714-02 |
| Megestrol Acetate | Megestrol acetate 40 mg/mL | SuspensionOral | ANI Pharmaceuticals, Inc. | 70954-896 | 70954-0896-1070954-0896-20 |
| Megestrol Acetate | Megestrol acetate 40 mg/mL | SuspensionOral | Natco Pharma USA LLC | 69339-160 | 69339-0160-1669339-0160-1769339-0160-18+1 more |
| Megestrol Acetate | Megestrol acetate 40 mg/mL | SuspensionOral | Precision Dose Inc. | 68094-063 | 68094-0063-6168094-0063-62 |
| Megestrol Acetate | Megestrol acetate 40 mg/mL | SuspensionOral | Precision Dose Inc. | 68094-174 | 68094-0174-62 |
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 400 mg/10mL | SuspensionOral | Major Pharmaceuticals | 0904-7577 |
| Megestrol Acetate | Megestrol acetate 40 mg/mL | SuspensionOral | American Health Packaging | 60687-916 |
| Megestrol Acetate | Megestrol acetate 40 mg/mL | SuspensionOral | ANI Pharmaceuticals, Inc. | 70954-896 |