FDA.reportPublic FDA data

Gemfibrozil

Product NDC
62135-160
11-digit product format
621350160
Labeler code
62135
Product ID
62135-160_2589e155-f097-67fc-e063-6294a90a20b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gemfibrozil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA074270
Marketing category
ANDA
Marketing start
1993-09-27
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
62135-160-31Gemfibrozil300 in 1 BOTTLETABLET, FILM COATED3003
62135-160-60Gemfibrozil60 in 1 BOTTLETABLET, FILM COATED603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-160-60EA - Each62135-16064af8580-120c-4ebe-becf-ee5a0bd10fe912024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-160GEMFIBROZIL TABLET, FILM COATED [CHARTWELL RX, LLC]3Current NDC, 2 package rows20241030_b8bb442e-66dc-435e-830c-4ba3daa47c04.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310459gemfibrozil 600 MG Oral TabletPSNb8bb442e-66dc-435e-830c-4ba3daa47c043
310459gemfibrozil 600 MG Oral TabletSCDb8bb442e-66dc-435e-830c-4ba3daa47c043

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62135-160-3162135016031300 TABLET, FILM COATED in 1 BOTTLE (62135-160-31) 2023-08-25NoNoCurrent
62135-160-606213501606060 TABLET, FILM COATED in 1 BOTTLE (62135-160-60) 2023-08-25NoNoCurrent