FDA.reportPublic FDA data

Gemfibrozil

Product NDC
72603-206
11-digit product format
726030206
Labeler code
72603
Product ID
72603-206_cc374f14-1a96-4262-bd13-9f126100050e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gemfibrozil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA202726
Marketing category
ANDA
Marketing start
2015-09-16
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
931dfe50-414f-e1ab-9c88-b15c4ba31929Product name520210615

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72603-206-01Gemfibrozil60 in 1 BOTTLETABLET, FILM COATED602
72603-206-02Gemfibrozil500 in 1 BOTTLETABLET, FILM COATED5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-206-01EA - Each72603-206bea0ef0d-a3f2-4ef5-b731-0b8b3c8bb3ba12024-06-10
72603-206-02EA - Each72603-2069dcf6f38-39b2-40b0-abf9-3d5ea916534b12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-206GEMFIBROZIL TABLET, FILM COATED [NORTHSTAR RX LLC]2Current NDC, 2 package rows20240516_b5e33ee2-f766-41d6-8a4b-7b4f0e961bf4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310459gemfibrozil 600 MG Oral TabletPSNb5e33ee2-f766-41d6-8a4b-7b4f0e961bf42
310459gemfibrozil 600 MG Oral TabletSCDb5e33ee2-f766-41d6-8a4b-7b4f0e961bf42
310459gemfibrozil 600 MG Oral TabletPSN16d0326a-a55b-448b-be24-a16182aaef5a1
310459gemfibrozil 600 MG Oral TabletPSNefecc680-f626-46bf-bc2b-3b5a72ba02671
310459gemfibrozil 600 MG Oral TabletSCD16d0326a-a55b-448b-be24-a16182aaef5a1
310459gemfibrozil 600 MG Oral TabletSCDefecc680-f626-46bf-bc2b-3b5a72ba02671

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72603-206-017260302060160 TABLET, FILM COATED in 1 BOTTLE (72603-206-01) 2015-09-16NoNoCurrent
72603-206-0272603020602500 TABLET, FILM COATED in 1 BOTTLE (72603-206-02) 2015-09-16NoNoCurrent