Prescription drug · ANDA
Megestrol Acetate NDC 17856-0060
Megestrol acetate 40 mg/mL · Suspension · Oral · ATLANTIC BIOLOGICALS CORP.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 17856-0060-3 | 17856006003 | 72 CUP in 1 BOX (17856-0060-3) / 10 mL in 1 CUP (17856-0060-1)Marketed from May 9, 2024 | |
| 17856-0060-4 | 17856006004 | 50 CUP in 1 BOX (17856-0060-4) / 20 mL in 1 CUP (17856-0060-2)Marketed from May 9, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- ATLANTIC BIOLOGICALS CORP.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075671
- Marketing start
- Listing expires
- Other FDA classes
- Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 17856-0060_5633adca-eb95-d0ae-e063-6394a90a3065SPL ID 5633adca-eb95-d0ae-e063-6394a90a3065SPL set ID 01119031-9943-4afb-8b45-cb71682f0482RxCUI 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
N417856006003followed by a unit qualifier and the quantityPackage 17856-0060-03. 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, USP 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 075671
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 | Precision Dose Inc. | 68094-174 |
| Megestrol Acetate | Megestrol acetate 40 mg/mL | SuspensionOral | Golden State Medical Supply, Inc. | 51407-910 |
| Megestrol Acetate | Megestrol acetate 40 mg/mL | SuspensionOral | Strides Pharma Science Limited | 64380-160 |
| Megestrol Acetate | Megestrol acetate 40 mg/mL | SuspensionOral | Natco Pharma USA LLC | 69339-160 |
| Megestrol Acetate | Megestrol acetate 400 mg/10mL | SuspensionOral | PAI Holdings, LLC dba PAI Pharma | 0121-0945 |
| Megestrol Acetate | Megestrol acetate 40 mg/mL | SuspensionOral | Precision Dose Inc. | 68094-063 |
| Megestrol Acetate | Megestrol acetate 40 mg/mL | SuspensionOral | Preferred Pharmaceuticals Inc. | 68788-8714 |
| Megestrol Acetate | Megestrol acetate 40 mg/mL | SuspensionOral | Kesin Pharma Corporation | 81033-150 |