Prescription drug · NDA
Proscar (finasteride) NDC 78206-153
Finasteride 5 mg/1 · Tablet, Film coated · Oral · Organon LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 78206-153-01 | 78206015301 | 30 TABLET, FILM COATED in 1 BOTTLE (78206-153-01)Marketed from Jun 1, 2021 | |
| 78206-153-02 | 78206015302 | 100 TABLET, FILM COATED in 1 BOTTLE (78206-153-02)Marketed from Jun 1, 2021 |
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)
- Proscar
- Generic name (nonproprietary)
- finasteride
- Active ingredients
- Finasteride — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Organon LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020180
- Marketing start
- Listing expires
- Other FDA classes
- 5-alpha Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 78206-153_979b0a0c-7868-4ec1-8887-f2b7e43f4326SPL ID 979b0a0c-7868-4ec1-8887-f2b7e43f4326SPL set ID 6f988153-fc74-4ca4-b29a-111f750c4a4bRxCUI 201961, 310346UNII 57GNO57U7GUPC 0378206153012
- 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
N478206015301followed by a unit qualifier and the quantityPackage 78206-0153-01. 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)
PROSCAR, 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. PROSCAR 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 : PROSCAR is not approved for the prevention of prostate cancer ( 1.3 ). 1.1 Monotherapy PROSCAR ® is indicated f…
Excerpt only. Read the full label for complete information.