FDA.reportPublic FDA data

Gemfibrozil

Product NDC
24658-260
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
931dfe50-414f-e1ab-9c88-b15c4ba31929Product name520210615
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
24658-260-052025-07-29C16284748780-13b156c62-3001-fb37-e063-e6dba90a4e07Gemfibrozil Tablets, USP
24658-260-182025-07-29C16284748780-13b156c62-3001-fb37-e063-e6dba90a4e07Gemfibrozil Tablets, USP
24658-260-302025-07-29C16284748780-13b156c62-3001-fb37-e063-e6dba90a4e07Gemfibrozil Tablets, USP
24658-260-602025-07-29C16284748780-13b156c62-3001-fb37-e063-e6dba90a4e07Gemfibrozil Tablets, USP
24658-260-902025-07-29C16284748780-13b156c62-3001-fb37-e063-e6dba90a4e07Gemfibrozil Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24658-260-05Gemfibrozil500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50021
24658-260-18Gemfibrozil180 in 1 BOTTLE, PLASTICTABLET, FILM COATED18021
24658-260-30Gemfibrozil30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3021
24658-260-60Gemfibrozil60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6021
24658-260-90Gemfibrozil90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24658-260-05EA - Each24658-26039e24f08-b112-413d-b7bd-b24c5181fb5a12012-07-24
24658-260-18EA - Each24658-2608b2eda9c-215e-4e26-a559-42042793720f12012-07-24
24658-260-60EA - Each24658-26039d001d1-0488-4221-acdc-48361162df5312012-07-24
24658-260-90EA - Each24658-2609dfb1b0e-3bca-496a-9223-2be70234263012013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GEMFIBROZILACTIVE INGREDIENTQ8X02027X3GEMFIBROZIL TABLET, FILM COATED [BLU PHARMACEUTICALS, LLC]13
GEMFIBROZILACTIVE MOIETYQ8X02027X3GEMFIBROZIL TABLET, FILM COATED [BLU PHARMACEUTICALS, LLC]13
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LGEMFIBROZIL TABLET, FILM COATED [BLU PHARMACEUTICALS, LLC]13
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZGEMFIBROZIL TABLET, FILM COATED [BLU PHARMACEUTICALS, LLC]13
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGEMFIBROZIL TABLET, FILM COATED [BLU PHARMACEUTICALS, LLC]13
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48GEMFIBROZIL TABLET, FILM COATED [BLU PHARMACEUTICALS, LLC]13
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PGEMFIBROZIL TABLET, FILM COATED [BLU PHARMACEUTICALS, LLC]13
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PGEMFIBROZIL TABLET, FILM COATED [BLU PHARMACEUTICALS, LLC]13
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990GEMFIBROZIL TABLET, FILM COATED [BLU PHARMACEUTICALS, LLC]13
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GEMFIBROZIL TABLET, FILM COATED [BLU PHARMACEUTICALS, LLC]13
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JGEMFIBROZIL TABLET, FILM COATED [BLU PHARMACEUTICALS, LLC]13
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGEMFIBROZIL TABLET, FILM COATED [BLU PHARMACEUTICALS, LLC]13
TALCINACTIVE INGREDIENT7SEV7J4R1UGEMFIBROZIL TABLET, FILM COATED [BLU PHARMACEUTICALS, LLC]13
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGEMFIBROZIL TABLET, FILM COATED [BLU PHARMACEUTICALS, LLC]13
GEMFIBROZILACTIVE INGREDIENTQ8X02027X3GEMFIBROZIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
GEMFIBROZILACTIVE MOIETYQ8X02027X3GEMFIBROZIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LGEMFIBROZIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZGEMFIBROZIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGEMFIBROZIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GEMFIBROZIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48GEMFIBROZIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PGEMFIBROZIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PGEMFIBROZIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990GEMFIBROZIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JGEMFIBROZIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJGEMFIBROZIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UGEMFIBROZIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGEMFIBROZIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
GEMFIBROZILACTIVE INGREDIENTQ8X02027X3GEMFIBROZIL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
GEMFIBROZILACTIVE MOIETYQ8X02027X3GEMFIBROZIL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LGEMFIBROZIL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZGEMFIBROZIL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGEMFIBROZIL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48GEMFIBROZIL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PGEMFIBROZIL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PGEMFIBROZIL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990GEMFIBROZIL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GEMFIBROZIL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JGEMFIBROZIL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGEMFIBROZIL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TALCINACTIVE INGREDIENT7SEV7J4R1UGEMFIBROZIL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGEMFIBROZIL TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24658-260GEMFIBROZIL TABLET, FILM COATED [PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS]21Legacy NDC, 5 package rows20231228_fdcee21a-097d-4354-bc91-e92cfdffac62.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310459gemfibrozil 600 MG Oral TabletPSNfdcee21a-097d-4354-bc91-e92cfdffac6221
310459gemfibrozil 600 MG Oral TabletSCDfdcee21a-097d-4354-bc91-e92cfdffac6221
310459gemfibrozil 600 MG Oral TabletPSNf4179a86-7f9c-4bbd-b10d-3507c8327dc92
310459gemfibrozil 600 MG Oral TabletSCDf4179a86-7f9c-4bbd-b10d-3507c8327dc92
310459gemfibrozil 600 MG Oral TabletPSN17529d33-f24a-1f3f-e063-6394a90ae3741
310459gemfibrozil 600 MG Oral TabletPSN8967a94c-be50-4018-9e9b-62856c81a6f01
310459gemfibrozil 600 MG Oral TabletSCD17529d33-f24a-1f3f-e063-6394a90ae3741
310459gemfibrozil 600 MG Oral TabletSCD8967a94c-be50-4018-9e9b-62856c81a6f01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24658-260-0524658026005500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (24658-260-05) 2011-04-010000-00-00NoNoCurrent
24658-260-1824658026018180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (24658-260-18) 2011-04-010000-00-00NoNoCurrent
24658-260-302465802603030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (24658-260-30) 2011-04-010000-00-00NoNoCurrent
24658-260-602465802606060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (24658-260-60) 2011-04-010000-00-00NoNoCurrent
24658-260-902465802609090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (24658-260-90) 2011-04-010000-00-00NoNoCurrent