Prescription drug · ANDA
Finasteride NDC 16729-090
Finasteride 5 mg/1 · Tablet, Film coated · Oral · Accord Healthcare, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16729-090-01 | 1672900900116729009001 | 100 TABLET, FILM COATED in 1 BOTTLE (16729-090-01)Marketed from Aug 24, 2010 | |
| 16729-090-10 | 1672900901016729009010 | 30 TABLET, FILM COATED in 1 BOTTLE (16729-090-10)Marketed from May 28, 2010 | |
| 16729-090-15 | 1672900901516729009015 | 90 TABLET, FILM COATED in 1 BOTTLE (16729-090-15)Marketed from Jun 8, 2010 | |
| 16729-090-16 | 1672900901616729009016 | 500 TABLET, FILM COATED in 1 BOTTLE (16729-090-16)Marketed from Nov 15, 2011 |
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 — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Accord Healthcare, Inc.NDC labeler code 16729
- 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 16729-090_5bb2ae57-cfe0-fd09-e063-6294a90a7ea0SPL ID 5bb2ae57-cfe0-fd09-e063-6294a90a7ea0
- 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
N416729009001followed by a unit qualifier and the quantityPackage 16729-0090-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 16729-090
- What is NDC 16729-090?
- 16729-090 is the product NDC for Finasteride, Finasteride 5 mg/1 tablet, film coated, listed with the FDA by Accord Healthcare, Inc.. It has 4 package NDCs, 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?
- Accord Healthcare, Inc., NDC labeler code 16729. 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 | Atlantic Biologicals Corps | 17856-0090 |
| 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 |