Prescription drug · ANDA
Finasteride NDC 17856-0090
Finasteride 5 mg/1 · Tablet, Film coated · Oral · Atlantic Biologicals Corps
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 17856-0090-1 | 1785600900117856009001 | 1 TABLET, FILM COATED in 1 POUCH (17856-0090-1)Marketed from Jan 11, 2021 |
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 — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Atlantic Biologicals CorpsNDC labeler code 17856
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090121
- Marketing start
- Listing expires
- Other FDA classes
- 5-alpha Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 17856-0090_385463d5-f3d9-96c0-e063-6294a90ac25eSPL ID 385463d5-f3d9-96c0-e063-6294a90ac25eSPL set ID 29e59387-120c-4367-9f87-75cb53b6460dRxCUI 310346UNII 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
N417856009001followed by a unit qualifier and the quantityPackage 17856-0090-01. 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, is a 5α-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to ( ): 1.1 Improve symptoms Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. Finasteride administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥4 point increase in American Urological Association (AUA) symptom score) ( ). 1.2 : Finasteride is not approved for the prevention of prostate cancer ( ). Limitations of Use 1.3 1.2 Combination with Alpha-Blocker Finasteride tablets USP, 5 mg admini…
Excerpt only. Read the full label for complete information.
About NDC 17856-0090
- What is NDC 17856-0090?
- 17856-0090 is the product NDC for Finasteride, Finasteride 5 mg/1 tablet, film coated, listed with the FDA by Atlantic Biologicals Corps. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Finasteride.
- What is the active ingredient?
- Finasteride.
- Who is the labeler?
- Atlantic Biologicals Corps, NDC labeler code 17856. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Finasteride?
- 68 other product NDCs are listed under this name. See all Finasteride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Finasteride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Finasteride | Finasteride 1 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4687 | 70518-4687-00 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1058 | 67046-1058-03 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-2639 | 55154-2639-00 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8749 | 68788-8749-0168788-8749-0368788-8749-06+1 more |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8433 | 68788-8433-0168788-8433-0368788-8433-06+1 more |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-542 | 72189-0542-3072189-0542-90 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals, Inc. | 68788-8377 | 68788-8377-0168788-8377-0368788-8377-06+1 more |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3616 | 70518-3616-0170518-3616-0370518-3616-04+1 more |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3600 | 70518-3600-0170518-3600-0370518-3600-04 |
| Finasteride | Finasteride 1 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 47335-714 | 47335-0714-0847335-0714-1847335-0714-81+2 more |
Other NDCs under ANDA 090121
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 5 mg/1 | Tablet, Film coatedOral | Accord Healthcare, Inc. | 16729-090 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-265 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3354 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3380 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0433 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1634 |