Prescription drug · ANDA
Finasteride NDC 71335-1304
Finasteride 1 mg/1 · Tablet, Coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1304-1 | 71335130401 | 30 TABLET, COATED in 1 BOTTLE (71335-1304-1)Marketed from Aug 16, 2019 | |
| 71335-1304-2 | 71335130402 | 90 TABLET, COATED in 1 BOTTLE (71335-1304-2)Marketed from Aug 16, 2019 | |
| 71335-1304-3 | 71335130403 | 60 TABLET, COATED in 1 BOTTLE (71335-1304-3)Marketed from Nov 20, 2019 | |
| 71335-1304-4 | 71335130404 | 28 TABLET, COATED in 1 BOTTLE (71335-1304-4)Marketed from May 30, 2024 | |
| 71335-1304-5 | 71335130405 | 180 TABLET, COATED in 1 BOTTLE (71335-1304-5)Marketed from Jun 5, 2020 |
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)
- Finasteride
- Generic name (nonproprietary)
- finasteride
- Active ingredients
- Finasteride — 1 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207750
- Marketing start
- Listing expires
- Other FDA classes
- 5-alpha Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 71335-1304_e1674f97-63e9-4580-b743-fa20ede60141SPL ID e1674f97-63e9-4580-b743-fa20ede60141SPL set ID 3e955ce4-d44e-4b4d-b763-ab141cb3f06dRxCUI 200172UNII 57GNO57U7G
- Pharmacologic class
- 5-alpha Reductase Inhibitor
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
N471335130401followed by a unit qualifier and the quantityPackage 71335-1304-01. 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)
Finasteride tablets is indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY . Efficacy in bitemporal recession has not been established. Finasteride tablets is not indicated for use in women. Finasteride tablets is a 5α-reductase inhibitor indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY ( 1 ). Finasteride tablets is not indicated for use in women ( 1 , 4 , 5.1 ).
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207750
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 |
|---|---|---|---|---|
| Finasteride | Finasteride 1 mg/1 | Tablet, CoatedOral | Ascend Laboratories, LLC | 67877-455 |
| Finasteride | Finasteride 1 mg/1 | Tablet, CoatedOral | A-S Medication Solutions | 50090-4648 |
| Finasteride | Finasteride 1 mg/1 | Tablet, CoatedOral | REMEDYREPACK INC. | 70518-2287 |
| Finasteride | Finasteride 1 mg/1 | Tablet, CoatedOral | Preferred Pharmaceuticals Inc. | 68788-8275 |
| Finasteride | Finasteride 1 mg/1 | TabletOral | Thirty Madison Inc | 71713-099 |
| Finasteride | Finasteride 1 mg/1 | Tablet, CoatedOral | NuCare Pharmaceuticals, Inc. | 68071-3744 |
| Finasteride | Finasteride 1 mg/1 | Tablet, CoatedOral | Proficient Rx LP | 71205-790 |