Prescription drug · ANDA
Finasteride NDC 0093-7355
Finasteride 5 mg/1 · Tablet, Film coated · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-7355-05 | 00093735505 | 500 TABLET, FILM COATED in 1 BOTTLE (0093-7355-05)Marketed from Mar 14, 2008 | |
| 0093-7355-56 | 00093735556 | 30 TABLET, FILM COATED in 1 BOTTLE (0093-7355-56)Marketed from Dec 15, 2006 | |
| 0093-7355-98 | 00093735598 | 90 TABLET, FILM COATED in 1 BOTTLE (0093-7355-98)Marketed from Feb 22, 2007 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076511
- Marketing start
- Marketing end
- Other FDA classes
- 5-alpha Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 0093-7355_0e34d8a4-1d1f-4466-8f46-f8dbf1ef9b34SPL ID 0e34d8a4-1d1f-4466-8f46-f8dbf1ef9b34SPL set ID 77589cc3-c440-4695-800c-82a0e5128a6cRxCUI 310346UNII 57GNO57U7GUPC 0300937355564
- 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
N400093735505followed by a unit qualifier and the quantityPackage 00093-7355-05. 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 acute urinary retention 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 ). Limitations of Use : Finasteride is not approved for the prevention of prostate cancer ( 1.3 ). 1.1 Monotherapy Finasteride …
Excerpt only. Read the full label for complete information.