Prescription drug · ANDA
Megestrol Acetate NDC 71335-2181
Megestrol acetate 40 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2181-1 | 71335218101 | 30 TABLET in 1 BOTTLE (71335-2181-1)Marketed from Oct 25, 2022 | |
| 71335-2181-2 | 71335218102 | 100 TABLET in 1 BOTTLE (71335-2181-2)Marketed from Oct 25, 2022 | |
| 71335-2181-3 | 71335218103 | 15 TABLET in 1 BOTTLE (71335-2181-3)Marketed from Oct 25, 2022 |
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/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 072423
- Marketing start
- Listing expires
- Other FDA classes
- Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 71335-2181_c46a0f6c-4c7e-4278-81c7-4439cdbaec1fSPL ID c46a0f6c-4c7e-4278-81c7-4439cdbaec1fSPL set ID dd6617df-0876-4fc5-8435-b53d29ccc1aeRxCUI 860221UNII 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
N471335218101followed by a unit qualifier and the quantityPackage 71335-2181-01. 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 tablets are indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (ie, recurrent, inoperable, or metastatic disease). It should not be used in lieu of currently accepted procedures such as surgery, radiation, or chemotherapy.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 072423
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/1 | TabletOral | Strides Pharma Science Limited | 64380-159 |
| Megestrol Acetate | Megestrol acetate 40 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7236 |