GEMFIBROZIL

Product NDC
61919-967
11-digit product format
619190967
Labeler code
61919
Product ID
61919-967_f21620df-a19c-7df4-e053-2995a90a00c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GEMFIBROZIL
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA077836
Marketing category
ANDA
Marketing start
2019-08-08
Marketing end
0000-00-00
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
2024-12-31
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
61919-967-302025-01-30C16284748780-12cef2736-887b-d83d-e063-dadaa90ab31fGEMFIBROZIL
61919-967-902025-01-30C16284748780-12cef2736-887b-d83d-e063-dadaa90ab31fGEMFIBROZIL
61919-967-602020-01-31C16284748780-19d75b9d0-b88a-f424-e053-dadaa90a57ceGEMFIBROZIL 600mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-967-30GEMFIBROZIL30 in 1 BOTTLETABLET304
61919-967-90GEMFIBROZIL90 in 1 BOTTLETABLET904
61919-967-60GEMFIBROZIL60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-967-30EA - Each61919-967009f6b4a-1fb6-475c-86e3-d0d22327e60f12019-09-05
61919-967-60EA - Each61919-9673978207d-13da-4196-acb9-275c41f04e8012017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-967GEMFIBROZIL TABLET [DIRECT_RX]4Legacy NDC, 2 package rows20230113_8f9cce0a-1073-3c21-e053-2a95a90a8b87.zip
61919-967GEMFIBROZIL TABLET [DIRECT RX]1Legacy NDC, 1 package rows20171027_5c87947c-42a1-f79e-e053-2a91aa0a8e01.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310459gemfibrozil 600 MG Oral TabletPSN8f9cce0a-1073-3c21-e053-2a95a90a8b874
310459gemfibrozil 600 MG Oral TabletSCD8f9cce0a-1073-3c21-e053-2a95a90a8b874
310459gemfibrozil 600 MG Oral TabletPSN5c87947c-42a1-f79e-e053-2a91aa0a8e011
310459gemfibrozil 600 MG Oral TabletSCD5c87947c-42a1-f79e-e053-2a91aa0a8e011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-967-306191909673030 TABLET in 1 BOTTLE (61919-967-30) 30 tablet2019-08-080000-00-00NoNoCurrent
61919-967-606191909676060 in 1 BOTTLEHistorical
61919-967-906191909679090 TABLET in 1 BOTTLE (61919-967-90) 90 tablet2019-08-080000-00-00NoNoCurrent