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NDC 67877-0288-01 Finasteride 5 mg/1 Details
Finasteride 5 mg/1
Finasteride is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Ascend Laboratories, LLC. The primary component is FINASTERIDE.
MedlinePlus Drug Summary
Finasteride (Proscar) is used alone or in combination with another medication (doxazosin [Cardura]) to treat benign prostatic hypertrophy (BPH, enlargement of the prostate gland). Finasteride is used to treat symptoms of BPH such as frequent and difficult urination and may reduce the chance of acute urinary retention (sudden inability to urinate). It also may decrease the chance that prostate surgery will be needed. Finasteride (Propecia) is also used to treat male pattern hair loss (gradual thinning of the hair on the scalp, leading to a receding hairline or balding on the top of the head in men.) Finasteride (Propecia) has not been shown to treat thinning hair at the temples and is not used to treat hair loss in women or children. Finasteride is in a class of medications called 5-alpha reductase inhibitors. Finasteride treats BPH by blocking the body's production of a male hormone that causes the prostate to enlarge. Finasteride treats male pattern hair loss by blocking the body's production of a male hormone in the scalp that stops hair growth.
Related Packages: 67877-0288-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Finasteride
Product Information
| NDC | 67877-0288 |
|---|---|
| Product ID | 67877-288_7f639f16-692c-431f-a6de-1c8e7aa6681a |
| Associated GPIs | 56851030000320 |
| GCN Sequence Number | 041440 |
| GCN Sequence Number Description | finasteride TABLET 5 MG ORAL |
| HIC3 | Q9B |
| HIC3 Description | BENIGN PROSTATIC HYPERTROPHY/MICTURITION AGENTS |
| GCN | 30521 |
| HICL Sequence Number | 006421 |
| HICL Sequence Number Description | FINASTERIDE |
| Brand/Generic | Generic |
| Proprietary Name | Finasteride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Finasteride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/1 |
| Substance Name | FINASTERIDE |
| Labeler Name | Ascend Laboratories, LLC |
| Pharmaceutical Class | 5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA204304 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 67877-0288-01 (67877028801)
| NDC Package Code | 67877-288-01 |
|---|---|
| Billing NDC | 67877028801 |
| Package | 100 TABLET, FILM COATED in 1 BOTTLE (67877-288-01) |
| Marketing Start Date | 2017-01-05 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |