Home NDC 0093-7355 Finasteride
Product NDC 0093-7355
11-digit product format 000937355
Labeler code 0093
Product ID 0093-7355_c5126a52-1e69-447d-800f-ba863246b7d7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Finasteride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA076511
Marketing category ANDA
Marketing start 2006-12-15
Marketing end 2026-09-30
Substance FINASTERIDE
Active strength 5 mg/1
Pharmacologic classes 5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]
NDC exclude flag No
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076511-001 FINASTERIDE FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076511-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A076511-001 FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076511-001 FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076511-001 FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076511-001 FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076511-001 FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076511-001 FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076511-001 FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076511-001 FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076511-001 FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076511-001 FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076511-001 FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076511-001 FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076511-001 FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076511-001 FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076511-001 FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076511-001 FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076511-001 FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076511-001 FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076511-001 FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076511-001 FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076511-001 FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076511-001 FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076511-001 FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076511-001 FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076511-001 FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076511-001 FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076511-001 FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076511-001 FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076511-001 FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076511-001 FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076511-001 FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076511-001 FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076511-001 FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076511-001 FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076511-001 FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076511-001 FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076511-001 FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076511-001 FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076511-001 FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076511-001 FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Finasteride Active Ingredients# Ingredient, Strength table Ingredient Strength FINASTERIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 57GNO57U7G Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310346 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0093-7355-05 Finasteride 500 in 1 BOTTLE TABLET, FILM COATED 500 21 0093-7355-56 Finasteride 30 in 1 BOTTLE TABLET, FILM COATED 30 21 0093-7355-98 Finasteride 90 in 1 BOTTLE TABLET, FILM COATED 90 21
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FINASTERIDE ACTIVE INGREDIENT 57GNO57U7G FINASTERIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 13 FINASTERIDE ACTIVE MOIETY 57GNO57U7G FINASTERIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 13 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 FINASTERIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 13 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FINASTERIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 13 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK FINASTERIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 13 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 FINASTERIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 13 INDIGOTINDISULFONATE SODIUM INACTIVE INGREDIENT D3741U8K7L FINASTERIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 13 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X FINASTERIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 13 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FINASTERIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 13 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ FINASTERIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 13 POLYETHYLENE GLYCOL 6000 INACTIVE INGREDIENT 30IQX730WE FINASTERIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 13 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X FINASTERIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 13 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J FINASTERIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 13 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 FINASTERIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 13 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FINASTERIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 13 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FINASTERIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 13 FINASTERIDE ACTIVE INGREDIENT 57GNO57U7G FINASTERIDE (FINASTERIDE) TABLET, FILM COATED [AVKARE, INC.] 5 FINASTERIDE ACTIVE MOIETY 57GNO57U7G FINASTERIDE (FINASTERIDE) TABLET, FILM COATED [AVKARE, INC.] 5 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 FINASTERIDE (FINASTERIDE) TABLET, FILM COATED [AVKARE, INC.] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FINASTERIDE (FINASTERIDE) TABLET, FILM COATED [AVKARE, INC.] 5 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK FINASTERIDE (FINASTERIDE) TABLET, FILM COATED [AVKARE, INC.] 5 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 FINASTERIDE (FINASTERIDE) TABLET, FILM COATED [AVKARE, INC.] 5 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X FINASTERIDE (FINASTERIDE) TABLET, FILM COATED [AVKARE, INC.] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FINASTERIDE (FINASTERIDE) TABLET, FILM COATED [AVKARE, INC.] 5 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ FINASTERIDE (FINASTERIDE) TABLET, FILM COATED [AVKARE, INC.] 5 POLYETHYLENE GLYCOL 6000 INACTIVE INGREDIENT 30IQX730WE FINASTERIDE (FINASTERIDE) TABLET, FILM COATED [AVKARE, INC.] 5 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X FINASTERIDE (FINASTERIDE) TABLET, FILM COATED [AVKARE, INC.] 5 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J FINASTERIDE (FINASTERIDE) TABLET, FILM COATED [AVKARE, INC.] 5 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 FINASTERIDE (FINASTERIDE) TABLET, FILM COATED [AVKARE, INC.] 5 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FINASTERIDE (FINASTERIDE) TABLET, FILM COATED [AVKARE, INC.] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FINASTERIDE (FINASTERIDE) TABLET, FILM COATED [AVKARE, INC.] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0093-7355 FINASTERIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] 18 Current NDC, Legacy NDC, 3 package rows 20220304_77589cc3-c440-4695-800c-82a0e5128a6c.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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 0093-7355-05 00093735505 500 TABLET, FILM COATED in 1 BOTTLE (0093-7355-05) 2008-03-14 2026-09-30 No No Current 0093-7355-56 00093735556 30 TABLET, FILM COATED in 1 BOTTLE (0093-7355-56) 2006-12-15 2026-09-30 No No Current 0093-7355-98 00093735598 90 TABLET, FILM COATED in 1 BOTTLE (0093-7355-98) 2007-02-22 2026-09-30 No No Current