Home NDC 0093-7355 Finasteride
Product NDC 0093-7355
11-digit product format 000937355
Labeler code 0093
Product ID 0093-7355_e0e9be8c-8610-4630-8676-8b2ab8d7ee3a
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 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 43 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 2026-09-14 22:38:34 2026-08 A076511-001 FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076511-001 FINASTERIDE 5MG TABLET / ORAL AB 2006-12-15 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2022-09-29 23:25 UTC 2022-09 A076511-001 AB 1 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076511-001 AB 1 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A076511-001 AB 1 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 Legacy NDC, 3 package rows 20220304_77589cc3-c440-4695-800c-82a0e5128a6c.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 0093-7355-05 00093735505 500 TABLET, FILM COATED in 1 BOTTLE (0093-7355-05) 2008-03-14 0000-00-00 No No Current 0093-7355-56 00093735556 30 TABLET, FILM COATED in 1 BOTTLE (0093-7355-56) 2006-12-15 0000-00-00 No No Current 0093-7355-98 00093735598 90 TABLET, FILM COATED in 1 BOTTLE (0093-7355-98) 2007-02-22 0000-00-00 No No Current