Prescription drug · ANDA
Finasteride NDC 35573-400
Finasteride 1 mg/1 · Tablet, Film coated · Oral · Burel Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 35573-400-99 | 35573040099 | 1000 TABLET, FILM COATED in 1 BOTTLE (35573-400-99)Marketed from Jul 13, 2018 |
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)
- Finasteride
- Generic name (nonproprietary)
- finasteride
- Active ingredients
- Finasteride — 1 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Burel Pharmaceuticals, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203687
- Marketing start
- Listing expires
- Other FDA classes
- 5-alpha Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 35573-400_6752dcb1-091e-40a9-a6e2-069d543398a7SPL ID 6752dcb1-091e-40a9-a6e2-069d543398a7SPL set ID c8516eaa-98d0-4eb1-bc65-aa765baea5dbRxCUI 200172UNII 57GNO57U7GUPC 0335573400996
- 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
N435573040099followed by a unit qualifier and the quantityPackage 35573-0400-99. 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 are indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY . Efficacy in bitemporal recession has not been established. Finasteride tablets are not indicated for use in women. Finasteride is a 5α-reductase inhibitor indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY (1) . Finasteride tablets are not indicated for use in women ( 1 , 4 , 5.1 ).
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203687
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, Film coatedOral | Asclemed USA, Inc. | 76420-151 |
| Finasteride | Finasteride 1 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4687 |
| Finasteride | Finasteride 1 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-6875 |
| Finasteride | Finasteride 1 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4808 |
| Finasteride | Finasteride 1 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-061 |
| Finasteride | Finasteride 1 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3993 |
| Finasteride | Finasteride 1 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-927 |