Home NDC 24658-260-30 Gemfibrozil
Product NDC 24658-260
Requested package NDC 24658-260-30
11-digit product format 246580260
Labeler code 24658
Product ID 24658-260_d9fcbead-7bdf-4eea-bef0-fc81270f48b6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gemfibrozil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PuraCap Laboratories LLC dba Blu Pharmaceuticals
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 No
Listing certified through 2021-12-31
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 24658-260 24658-260-30 I Inactivated by FDA excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 24658-260 24658-260-30 I Inactivated by FDA excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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 24658-260-05 Gemfibrozil 500 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 500 21 24658-260-18 Gemfibrozil 180 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 180 21 24658-260-30 Gemfibrozil 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 21 24658-260-60 Gemfibrozil 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 21 24658-260-90 Gemfibrozil 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 21
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded GEMFIBROZIL ACTIVE INGREDIENT Q8X02027X3 GEMFIBROZIL TABLET, FILM COATED [BLU PHARMACEUTICALS, LLC] 13 GEMFIBROZIL ACTIVE MOIETY Q8X02027X3 GEMFIBROZIL TABLET, FILM COATED [BLU PHARMACEUTICALS, LLC] 13 CALCIUM STEARATE INACTIVE INGREDIENT 776XM7047L GEMFIBROZIL TABLET, FILM COATED [BLU PHARMACEUTICALS, LLC] 13 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ GEMFIBROZIL TABLET, FILM COATED [BLU PHARMACEUTICALS, LLC] 13 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U GEMFIBROZIL TABLET, FILM COATED [BLU PHARMACEUTICALS, LLC] 13 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 GEMFIBROZIL TABLET, FILM COATED [BLU PHARMACEUTICALS, LLC] 13 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P GEMFIBROZIL TABLET, FILM COATED [BLU PHARMACEUTICALS, LLC] 13 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P GEMFIBROZIL TABLET, FILM COATED [BLU PHARMACEUTICALS, LLC] 13 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 GEMFIBROZIL TABLET, FILM COATED [BLU PHARMACEUTICALS, LLC] 13 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 GEMFIBROZIL TABLET, FILM COATED [BLU PHARMACEUTICALS, LLC] 13 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J GEMFIBROZIL TABLET, FILM COATED [BLU PHARMACEUTICALS, LLC] 13 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ GEMFIBROZIL TABLET, FILM COATED [BLU PHARMACEUTICALS, LLC] 13 TALC INACTIVE INGREDIENT 7SEV7J4R1U GEMFIBROZIL TABLET, FILM COATED [BLU PHARMACEUTICALS, LLC] 13 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP GEMFIBROZIL TABLET, FILM COATED [BLU PHARMACEUTICALS, LLC] 13 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 GEMFIBROZIL ACTIVE INGREDIENT Q8X02027X3 GEMFIBROZIL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 GEMFIBROZIL ACTIVE MOIETY Q8X02027X3 GEMFIBROZIL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CALCIUM STEARATE INACTIVE INGREDIENT 776XM7047L GEMFIBROZIL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ GEMFIBROZIL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U GEMFIBROZIL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 GEMFIBROZIL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P GEMFIBROZIL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P GEMFIBROZIL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 GEMFIBROZIL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 GEMFIBROZIL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J GEMFIBROZIL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ GEMFIBROZIL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U GEMFIBROZIL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP GEMFIBROZIL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 24658-260 GEMFIBROZIL TABLET, FILM COATED [PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS] 21 Legacy NDC, 5 package rows 20231228_fdcee21a-097d-4354-bc91-e92cfdffac62.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 Marketing end Sample Exclude flag Status 24658-260-30 24658026030 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (24658-260-30) 2011-04-01 0000-00-00 No No Current