Home NDC 71610-824 Gemfibrozil
Product NDC 71610-824
11-digit product format 716100824
Labeler code 71610
Product ID 71610-824_17529d33-f24b-1f3f-e063-6394a90ae374
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gemfibrozil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA078012
Marketing category ANDA
Marketing start 2011-04-01
Substance GEMFIBROZIL
Active strength 600 mg/1
Pharmacologic classes PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [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 A078012-001 GEMFIBROZIL GEMFIBROZIL 600MG TABLET / ORAL AB 2007-03-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078012-001 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 A078012-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2007-03-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078012-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2007-03-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078012-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2007-03-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078012-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2007-03-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078012-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2007-03-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078012-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2007-03-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078012-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2007-03-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078012-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2007-03-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078012-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2007-03-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078012-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2007-03-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078012-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2007-03-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078012-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2007-03-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078012-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2007-03-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078012-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2007-03-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078012-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2007-03-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078012-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2007-03-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078012-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2007-03-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078012-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2007-03-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078012-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2007-03-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078012-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2007-03-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078012-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2007-03-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078012-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2007-03-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078012-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2007-03-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078012-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2007-03-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078012-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2007-03-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078012-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2007-03-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078012-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2007-03-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078012-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2007-03-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078012-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2007-03-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078012-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2007-03-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078012-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2007-03-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078012-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2007-03-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078012-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2007-03-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078012-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2007-03-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078012-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2007-03-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078012-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2007-03-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078012-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2007-03-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078012-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2007-03-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078012-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2007-03-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078012-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2007-03-26 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 Gemfibrozil
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GEMFIBROZIL 600 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Q8X02027X3 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310459 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 71610-824-30 Gemfibrozil 30 in 1 BOTTLE TABLET, FILM COATED 30 1 71610-824-53 Gemfibrozil 60 in 1 BOTTLE TABLET, FILM COATED 60 1 71610-824-60 Gemfibrozil 90 in 1 BOTTLE TABLET, FILM COATED 90 1 71610-824-80 Gemfibrozil 180 in 1 BOTTLE TABLET, FILM COATED 180 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-824 GEMFIBROZIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ] 1 Current NDC, 4 package rows 20240502_17529d33-f24a-1f3f-e063-6394a90ae374.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 71610-824-30 71610082430 30 TABLET, FILM COATED in 1 BOTTLE (71610-824-30) 2024-04-29 No No Current 71610-824-53 71610082453 60 TABLET, FILM COATED in 1 BOTTLE (71610-824-53) 2024-04-29 No No Current 71610-824-60 71610082460 90 TABLET, FILM COATED in 1 BOTTLE (71610-824-60) 2024-04-29 No No Current 71610-824-80 71610082480 180 TABLET, FILM COATED in 1 BOTTLE (71610-824-80) 2024-04-29 No No Current