Finasteride
- Product NDC
- 47335-714
- 11-digit product format
- 473350714
- Labeler code
- 47335
- Product ID
- 47335-714_3fb7fc89-95b5-4c8a-9b1c-dd509cadb4eb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Finasteride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA090508
- Marketing category
- ANDA
- Marketing start
- 2022-11-23
- Substance
- FINASTERIDE
- Active strength
- 1 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 | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 57GNO57U7G |
| Rxcui | 200172 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 47335-714-08 | Finasteride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 9 |
| 47335-714-18 | Finasteride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 9 |
| 47335-714-81 | Finasteride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 9 |
| 47335-714-83 | Finasteride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 9 |
| 47335-714-88 | Finasteride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FINASTERIDE | ACTIVE INGREDIENT | 57GNO57U7G | FINASTERIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 5 | |
| FINASTERIDE | ACTIVE MOIETY | 57GNO57U7G | FINASTERIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | FINASTERIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 5 | |
| DOCUSATE SODIUM | INACTIVE INGREDIENT | F05Q2T2JA0 | FINASTERIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 5 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | FINASTERIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 5 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | FINASTERIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 5 | |
| HYPROMELLOSE 2910 (15 MPA.S) | INACTIVE INGREDIENT | 36SFW2JZ0W | FINASTERIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 5 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | FINASTERIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | FINASTERIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 5 | |
| POLYETHYLENE GLYCOL 6000 | INACTIVE INGREDIENT | 30IQX730WE | FINASTERIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 5 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | FINASTERIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 5 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | FINASTERIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 5 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | FINASTERIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 5 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | FINASTERIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | FINASTERIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47335-714 | FINASTERIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 9 | Current NDC, Legacy NDC, 5 package rows | 20221123_abd87058-923f-4767-986c-278201c0e688.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 |
|---|
| 47335-714-08 | 47335071408 | 100 TABLET, FILM COATED in 1 BOTTLE (47335-714-08) | 2022-11-23 | 0000-00-00 | No | No | Current |
| 47335-714-18 | 47335071418 | 1000 TABLET, FILM COATED in 1 BOTTLE (47335-714-18) | 2022-11-23 | 0000-00-00 | No | No | Current |
| 47335-714-81 | 47335071481 | 90 TABLET, FILM COATED in 1 BOTTLE (47335-714-81) | 2022-11-23 | 0000-00-00 | No | No | Current |
| 47335-714-83 | 47335071483 | 30 TABLET, FILM COATED in 1 BOTTLE (47335-714-83) | 2022-11-23 | 0000-00-00 | No | No | Current |
| 47335-714-88 | 47335071488 | 100 TABLET, FILM COATED in 1 BOTTLE (47335-714-88) | 2022-11-23 | 0000-00-00 | No | No | Current |