Gemfibrozil

Product NDC
68071-2422
11-digit product format
680712422
Labeler code
68071
Product ID
68071-2422_c3542eba-3c1e-57ba-e053-2995a90a517b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gemfibrozil
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA079072
Marketing category
ANDA
Marketing start
2010-12-20
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2422-82023-01-30C16284748780-1f386c649-c255-0266-e053-dadaa90a7c1aRx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2422-8Gemfibrozil180 in 1 BOTTLETABLET18024

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2422GEMFIBROZIL TABLET [NUCARE PHARMACEUTICALS,INC.]24Legacy NDC, 1 package rows20210528_c3542eba-3c1d-57ba-e053-2995a90a517b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310459gemfibrozil 600 MG Oral TabletPSNc3542eba-3c1d-57ba-e053-2995a90a517b24
310459gemfibrozil 600 MG Oral TabletSCDc3542eba-3c1d-57ba-e053-2995a90a517b24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2422-868071242208180 TABLET in 1 BOTTLE (68071-2422-8) 180 tablet2021-05-270000-00-00NoNoCurrent