Home NDC 50090-6913 Gemfibrozil
Product NDC 50090-6913
11-digit product format 500906913
Labeler code 50090
Product ID 50090-6913_f0729765-9ea7-4acf-813b-f4de1fa5b717
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name gemfibrozil
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
Application ANDA079072
Marketing category ANDA
Marketing start 2010-12-20
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 A079072-001 GEMFIBROZIL GEMFIBROZIL 600MG TABLET / ORAL AB 2010-09-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A079072-001 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 A079072-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2010-09-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A079072-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2010-09-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079072-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2010-09-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079072-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2010-09-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079072-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2010-09-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079072-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2010-09-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079072-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2010-09-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079072-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2010-09-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079072-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2010-09-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079072-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2010-09-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079072-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2010-09-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079072-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2010-09-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079072-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2010-09-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079072-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2010-09-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A079072-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2010-09-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079072-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2010-09-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A079072-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2010-09-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A079072-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2010-09-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A079072-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2010-09-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A079072-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2010-09-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A079072-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2010-09-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A079072-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2010-09-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A079072-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2010-09-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A079072-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2010-09-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A079072-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2010-09-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A079072-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2010-09-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A079072-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2010-09-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A079072-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2010-09-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A079072-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2010-09-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A079072-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2010-09-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A079072-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2010-09-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A079072-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2010-09-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A079072-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2010-09-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A079072-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2010-09-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A079072-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2010-09-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A079072-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2010-09-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A079072-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2010-09-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A079072-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2010-09-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A079072-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2010-09-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A079072-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2010-09-13 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 50090-6913-0 Gemfibrozil 60 in 1 BOTTLE TABLET 60 1 50090-6913-2 Gemfibrozil 90 in 1 BOTTLE TABLET 90 1 50090-6913-3 Gemfibrozil 30 in 1 BOTTLE TABLET 30 1 50090-6913-4 Gemfibrozil 180 in 1 BOTTLE TABLET 180 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-6913 GEMFIBROZIL TABLET [A-S MEDICATION SOLUTIONS] 1 Current NDC, 4 package rows 20231219_4907bbfa-27f4-4569-8957-9704f9c998a0.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50090-6913-0 50090691300 60 TABLET in 1 BOTTLE (50090-6913-0) 60 tablet 2023-12-12 No No Current 50090-6913-2 50090691302 90 TABLET in 1 BOTTLE (50090-6913-2) 90 tablet 2023-12-12 No No Current 50090-6913-3 50090691303 30 TABLET in 1 BOTTLE (50090-6913-3) 30 tablet 2023-12-12 No No Current 50090-6913-4 50090691304 180 TABLET in 1 BOTTLE (50090-6913-4) 180 tablet 2023-12-12 No No Current