Home NDC 43598-390 Finasteride
Product NDC 43598-390
11-digit product format 435980390
Labeler code 43598
Product ID 43598-390_47e5c3f0-f718-b400-c5f7-ba0057fdf6b1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Finasteride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Dr Reddys Laboratories Inc
Application ANDA090060
Marketing category ANDA
Marketing start 2014-06-10
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A090060-001 FINASTERIDE FINASTERIDE 1MG TABLET / ORAL AB 2013-07-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090060-001 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 · 42 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 2026-08-18 06:07:40 2026-07 A090060-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-07-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090060-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-07-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090060-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-07-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090060-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-07-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090060-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-07-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090060-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-07-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090060-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-07-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090060-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-07-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090060-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-07-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090060-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-07-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090060-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-07-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090060-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-07-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090060-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-07-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090060-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-07-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090060-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-07-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090060-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-07-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090060-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-07-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090060-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-07-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090060-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-07-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090060-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-07-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090060-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-07-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090060-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-07-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090060-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-07-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090060-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-07-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090060-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-07-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090060-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-07-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090060-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-07-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090060-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-07-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090060-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-07-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090060-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-07-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090060-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-07-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090060-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-07-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090060-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-07-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090060-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-07-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090060-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-07-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090060-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-07-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090060-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-07-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090060-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-07-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090060-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-07-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090060-001 FINASTERIDE 1MG TABLET / ORAL AB 2013-07-01 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 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 200172 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 43598-390-30 Finasteride 30 in 1 BOTTLE TABLET, FILM COATED 30 4 43598-390-90 Finasteride 90 in 1 BOTTLE TABLET, FILM COATED 90 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FINASTERIDE ACTIVE INGREDIENT 57GNO57U7G FINASTERIDE TABLET, FILM COATED [DR REDDYS LABORATORIES INC] 1 FINASTERIDE ACTIVE MOIETY 57GNO57U7G FINASTERIDE TABLET, FILM COATED [DR REDDYS LABORATORIES INC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FINASTERIDE TABLET, FILM COATED [DR REDDYS LABORATORIES INC] 1 DOCUSATE SODIUM INACTIVE INGREDIENT F05Q2T2JA0 FINASTERIDE TABLET, FILM COATED [DR REDDYS LABORATORIES INC] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 FINASTERIDE TABLET, FILM COATED [DR REDDYS LABORATORIES INC] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT FINASTERIDE TABLET, FILM COATED [DR REDDYS LABORATORIES INC] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO FINASTERIDE TABLET, FILM COATED [DR REDDYS LABORATORIES INC] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X FINASTERIDE TABLET, FILM COATED [DR REDDYS LABORATORIES INC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FINASTERIDE TABLET, FILM COATED [DR REDDYS LABORATORIES INC] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 FINASTERIDE TABLET, FILM COATED [DR REDDYS LABORATORIES INC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FINASTERIDE TABLET, FILM COATED [DR REDDYS LABORATORIES INC] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U FINASTERIDE TABLET, FILM COATED [DR REDDYS LABORATORIES INC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FINASTERIDE TABLET, FILM COATED [DR REDDYS LABORATORIES INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43598-390 FINASTERIDE TABLET, FILM COATED [DR REDDYS LABORATORIES INC] 4 Current NDC, Legacy NDC, 2 package rows 20241222_9acbe693-8448-b443-9f78-1f9972520798.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 · 4 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 43598-390-30 43598039030 30 TABLET, FILM COATED in 1 BOTTLE (43598-390-30) 2014-06-10 0000-00-00 No No Current 43598-390-90 43598039090 90 TABLET, FILM COATED in 1 BOTTLE (43598-390-90) 2014-06-10 0000-00-00 No No Current