Home NDC 43353-772 Gemfibrozil
Product NDC 43353-772
11-digit product format 433530772
Labeler code 43353
Product ID 43353-772_23a800db-9bfe-464f-9fc2-5090f2fa6840
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gemfibrozil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, Inc.
Application ANDA078012
Marketing category ANDA
Marketing start 2011-04-01
Marketing end 0000-00-00
Substance GEMFIBROZIL
Active strength 600 mg/1
Pharmacologic classes Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 43353-772-60 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 43353-772-60 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 43353-772-60 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 43353-772-60 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 43353-772-60 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 43353-772-60 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 43353-772-60 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 43353-772-60 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 43353-772-60 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 43353-772-60 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 43353-772-60 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 43353-772-60 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 43353-772-60 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 43353-772-60 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 43353-772-60 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 43353-772-60 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 43353-772-60 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 43353-772-60 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 43353-772-60 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 43353-772-60 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 43353-772-60 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 43353-772-60 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 · 41 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 2026-02-19 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…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078012-001 GEMFIBROZIL 600MG TABLET / ORAL AB 2007-03-26 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43353-772-60 Gemfibrozil 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded GEMFIBROZIL ACTIVE INGREDIENT Q8X02027X3 GEMFIBROZIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 2 GEMFIBROZIL ACTIVE MOIETY Q8X02027X3 GEMFIBROZIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 2 CALCIUM STEARATE INACTIVE INGREDIENT 776XM7047L GEMFIBROZIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 2 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ GEMFIBROZIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U GEMFIBROZIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 2 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 GEMFIBROZIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 GEMFIBROZIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 2 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P GEMFIBROZIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 2 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P GEMFIBROZIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 2 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 GEMFIBROZIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J GEMFIBROZIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 2 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ GEMFIBROZIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U GEMFIBROZIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP GEMFIBROZIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-772 GEMFIBROZIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 2 Legacy NDC, 1 package rows 20120329_f4179a86-7f9c-4bbd-b10d-3507c8327dc9.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 Status 43353-772-60 43353077260 90 in 1 BOTTLE, PLASTIC Historical