FDA.reportPublic FDA data

Gemfibrozil

Product NDC
71610-824
11-digit product format
716100824
Labeler code
71610
Product ID
71610-824_17529d33-f24b-1f3f-e063-6394a90ae374
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gemfibrozil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA078012
Marketing category
ANDA
Marketing start
2011-04-01
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

Additional Listing Data#

Finished product
Yes
Brand name base
Gemfibrozil
Listing expiration
2026-12-31

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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-824-30Gemfibrozil30 in 1 BOTTLETABLET, FILM COATED301
71610-824-53Gemfibrozil60 in 1 BOTTLETABLET, FILM COATED601
71610-824-60Gemfibrozil90 in 1 BOTTLETABLET, FILM COATED901
71610-824-80Gemfibrozil180 in 1 BOTTLETABLET, FILM COATED1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-824-30EA - Each71610-824b5336afc-db86-47db-b954-b5d8dcda603512024-06-10
71610-824-53EA - Each71610-82453b33d5a-365b-41f9-9699-0ef1a5863dc212024-06-10
71610-824-60EA - Each71610-82464cdb549-49b8-4064-b312-60f88ad2c85712024-06-10
71610-824-80EA - Each71610-82423026d6a-24ca-4cf2-a722-1a68e4f3bca312024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-824GEMFIBROZIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]1Current NDC, 4 package rows20240502_17529d33-f24a-1f3f-e063-6394a90ae374.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310459gemfibrozil 600 MG Oral TabletPSN17529d33-f24a-1f3f-e063-6394a90ae3741
310459gemfibrozil 600 MG Oral TabletSCD17529d33-f24a-1f3f-e063-6394a90ae3741

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71610-824-307161008243030 TABLET, FILM COATED in 1 BOTTLE (71610-824-30) 2024-04-29NoNoCurrent
71610-824-537161008245360 TABLET, FILM COATED in 1 BOTTLE (71610-824-53) 2024-04-29NoNoCurrent
71610-824-607161008246090 TABLET, FILM COATED in 1 BOTTLE (71610-824-60) 2024-04-29NoNoCurrent
71610-824-8071610082480180 TABLET, FILM COATED in 1 BOTTLE (71610-824-80) 2024-04-29NoNoCurrent