Finasteride
- Product NDC
- 63187-265
- 11-digit product format
- 631870265
- Labeler code
- 63187
- Product ID
- 63187-265_8438d683-b2a2-476b-8511-e2b74829e90b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- finasteride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA090121
- Marketing category
- ANDA
- Marketing start
- 2010-05-28
- Substance
- FINASTERIDE
- Active strength
- 5 mg/1
- Pharmacologic classes
- 5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Finasteride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FINASTERIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 57GNO57U7G |
| Rxcui | 310346 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-265-10 | Finasteride | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 6 |
| 63187-265-30 | Finasteride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 6 |
| 63187-265-60 | Finasteride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 6 |
| 63187-265-90 | Finasteride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FINASTERIDE | ACTIVE INGREDIENT | 57GNO57U7G | FINASTERIDE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| FINASTERIDE | ACTIVE MOIETY | 57GNO57U7G | FINASTERIDE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | FINASTERIDE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | FINASTERIDE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | FINASTERIDE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | FINASTERIDE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | FINASTERIDE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| POLYETHYLENE GLYCOL 6000 | INACTIVE INGREDIENT | 30IQX730WE | FINASTERIDE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | FINASTERIDE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | FINASTERIDE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | FINASTERIDE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-265 | FINASTERIDE TABLET, FILM COATED [PROFICIENT RX LP] | 6 | Current NDC, Legacy NDC, 4 package rows | 20220416_e9ea2f77-11c3-4dbf-bdc4-d1b0e7437990.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63187-265-10 | 63187026510 | 10 TABLET, FILM COATED in 1 BOTTLE (63187-265-10) | 2022-02-11 | 0000-00-00 | No | No | Current |
| 63187-265-30 | 63187026530 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-265-30) | 2014-11-03 | 0000-00-00 | No | No | Current |
| 63187-265-60 | 63187026560 | 60 TABLET, FILM COATED in 1 BOTTLE (63187-265-60) | 2017-07-03 | 0000-00-00 | No | No | Current |
| 63187-265-90 | 63187026590 | 90 TABLET, FILM COATED in 1 BOTTLE (63187-265-90) | 2017-07-03 | 0000-00-00 | No | No | Current |