FDA.reportPublic FDA data

Gemfibrozil

Product NDC
70518-1563
11-digit product format
705181563
Labeler code
70518
Product ID
70518-1563_5102f566-8b6c-c12f-e063-6294a90ad80b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gemfibrozil
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077836
Marketing category
ANDA
Marketing start
2018-10-22
Substance
GEMFIBROZIL
Active strength
600 mg/1
Pharmacologic classes
Fibric Acids [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gemfibrozil
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GEMFIBROZIL600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ8X02027X3
Rxcui310459

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
931dfe50-414f-e1ab-9c88-b15c4ba31929Product name520210615

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-1563-0Gemfibrozil45 in 1 BOTTLE, PLASTICTABLET4521
70518-1563-1Gemfibrozil30 in 1 BLISTER PACKTABLET3021
70518-1563-2Gemfibrozil90 in 1 BOTTLE, PLASTICTABLET9021
70518-1563-3Gemfibrozil180 in 1 BOTTLE, PLASTICTABLET18021
70518-1563-4Gemfibrozil100 in 1 BOXTABLET10021
70518-1563-5Gemfibrozil1 in 1 POUCHTABLET121
70518-1563-6Gemfibrozil60 in 1 BOTTLE, PLASTICTABLET6021

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1563GEMFIBROZIL TABLET [REMEDYREPACK INC.]16Current NDC, Legacy NDC, 7 package rows20250501_4260d746-bb58-4e10-9ffe-fc414f22b591.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310459gemfibrozil 600 MG Oral TabletPSN4260d746-bb58-4e10-9ffe-fc414f22b59121
310459gemfibrozil 600 MG Oral TabletSCD4260d746-bb58-4e10-9ffe-fc414f22b59121

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1563-07051815630045 TABLET in 1 BOTTLE, PLASTIC (70518-1563-0) 45 tablet2018-10-220000-00-00NoNoCurrent
70518-1563-17051815630130 TABLET in 1 BLISTER PACK (70518-1563-1) 30 tablet2018-10-230000-00-00NoNoCurrent
70518-1563-27051815630290 TABLET in 1 BOTTLE, PLASTIC (70518-1563-2) 90 tablet2019-04-030000-00-00NoNoCurrent
70518-1563-370518156303180 TABLET in 1 BOTTLE, PLASTIC (70518-1563-3) 180 tablet2020-02-110000-00-00NoNoCurrent
70518-1563-470518156304100 in 1 BOXHistorical
70518-1563-5705181563051 in 1 POUCHHistorical
70518-1563-67051815630660 TABLET in 1 BOTTLE, PLASTIC (70518-1563-6) 60 tablet2025-07-01NoNoCurrent