Prescription drug · ANDA
Megestrol Acetate NDC 64380-160
Megestrol acetate 40 mg/mL · Suspension · Oral · Strides Pharma Science Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64380-160-01 | 64380016001 | 240 mL in 1 BOTTLE, PLASTIC (64380-160-01)Marketed from Mar 21, 2022 | |
| 64380-160-02 | 64380016002 | 480 mL in 1 BOTTLE, PLASTIC (64380-160-02)Marketed from Mar 21, 2022 |
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
- 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 64380-160_d842f1ed-8df5-4fe9-a694-5da7a042134eSPL ID d842f1ed-8df5-4fe9-a694-5da7a042134eSPL set ID 9f7365a0-67cf-45fc-a914-e40a4507a063RxCUI 860225UNII TJ2M0FR8ESUPC 0364380160014
- 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
N464380016001followed by a unit qualifier and the quantityPackage 64380-0160-01. 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 | 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 | ATLANTIC BIOLOGICALS CORP. | 17856-0060 |
| 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 |