Home NDC 68382-553 Gemfibrozil
Product NDC 68382-553
11-digit product format 683820553
Labeler code 68382
Product ID 68382-553_9c4294b2-eee2-42d7-b260-6fc2e7e28833
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gemfibrozil
Dosage form TABLET
Route ORAL
Labeler Zydus Pharmaceuticals (USA) Inc.
Application ANDA204189
Marketing category ANDA
Marketing start 2019-01-15
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 A204189-001 GEMFIBROZIL GEMFIBROZIL 600MG TABLET / ORAL 2018-08-28
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 A204189-001 GEMFIBROZIL 600MG TABLET / ORAL 2018-08-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204189-001 GEMFIBROZIL 600MG TABLET / ORAL 2018-08-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204189-001 GEMFIBROZIL 600MG TABLET / ORAL 2018-08-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204189-001 GEMFIBROZIL 600MG TABLET / ORAL 2018-08-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204189-001 GEMFIBROZIL 600MG TABLET / ORAL 2018-08-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204189-001 GEMFIBROZIL 600MG TABLET / ORAL 2018-08-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204189-001 GEMFIBROZIL 600MG TABLET / ORAL 2018-08-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204189-001 GEMFIBROZIL 600MG TABLET / ORAL 2018-08-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204189-001 GEMFIBROZIL 600MG TABLET / ORAL 2018-08-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204189-001 GEMFIBROZIL 600MG TABLET / ORAL 2018-08-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204189-001 GEMFIBROZIL 600MG TABLET / ORAL 2018-08-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204189-001 GEMFIBROZIL 600MG TABLET / ORAL 2018-08-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204189-001 GEMFIBROZIL 600MG TABLET / ORAL 2018-08-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204189-001 GEMFIBROZIL 600MG TABLET / ORAL 2018-08-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204189-001 GEMFIBROZIL 600MG TABLET / ORAL 2018-08-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204189-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2018-08-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204189-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2018-08-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204189-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2018-08-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204189-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2018-08-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204189-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2018-08-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204189-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2018-08-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204189-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2018-08-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204189-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2018-08-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204189-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2018-08-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204189-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2018-08-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204189-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2018-08-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204189-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2018-08-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204189-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2018-08-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204189-001 GEMFIBROZIL 600MG TABLET / ORAL 2018-08-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204189-001 GEMFIBROZIL 600MG TABLET / ORAL 2018-08-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204189-001 GEMFIBROZIL 600MG TABLET / ORAL 2018-08-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204189-001 GEMFIBROZIL 600MG TABLET / ORAL 2018-08-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204189-001 GEMFIBROZIL 600MG TABLET / ORAL 2018-08-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204189-001 GEMFIBROZIL 600MG TABLET / ORAL 2018-08-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204189-001 GEMFIBROZIL 600MG TABLET / ORAL 2018-08-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204189-001 GEMFIBROZIL 600MG TABLET / ORAL 2018-08-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204189-001 GEMFIBROZIL 600MG TABLET / ORAL 2018-08-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204189-001 GEMFIBROZIL 600MG TABLET / ORAL 2018-08-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204189-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2018-08-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204189-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2018-08-28 e64feba35796…
Observed Orange Book normalized TE history# 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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68382-553 GEMFIBROZIL TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] 3 Current NDC, Legacy NDC, 8 package rows 20241109_556945e8-4100-4538-bcba-af5b2f13a7e8.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 Marketing end Sample Exclude flag Status 68382-553-01 68382055301 100 TABLET in 1 BOTTLE (68382-553-01) 100 tablet 2019-01-15 0000-00-00 No No Current 68382-553-05 68382055305 500 TABLET in 1 BOTTLE (68382-553-05) 500 tablet 2019-01-15 0000-00-00 No No Current 68382-553-06 68382055306 30 TABLET in 1 BOTTLE (68382-553-06) 30 tablet 2019-01-15 0000-00-00 No No Current 68382-553-10 68382055310 1000 TABLET in 1 BOTTLE (68382-553-10) 1000 tablet 2019-01-15 0000-00-00 No No Current 68382-553-14 68382055314 60 TABLET in 1 BOTTLE (68382-553-14) 60 tablet 2019-01-15 0000-00-00 No No Current 68382-553-16 68382055316 90 TABLET in 1 BOTTLE (68382-553-16) 90 tablet 2019-01-15 0000-00-00 No No Current 68382-553-30 68382055330 10 BLISTER PACK in 1 CARTON (68382-553-30) / 10 TABLET in 1 BLISTER PACK 10 blister pack 2019-01-15 0000-00-00 No No Current