FDA.reportPublic FDA data

Gemfibrozil

Product NDC
51655-142
11-digit product format
516550142
Labeler code
51655
Product ID
51655-142_b8b092e5-6eb9-4a6b-98e6-2f71f687f9ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gemfibrozil
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Pharmaceuticals, LLC
Application
ANDA077836
Marketing category
ANDA
Marketing start
2014-10-23
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
2019-12-31
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
51655-142-262026-01-10C16284748780-19d75b9d0-f8b3-f424-e053-dadaa90a57ceGemfibrozil
51655-142-302026-01-10C16284748780-19d75b9d0-f8b3-f424-e053-dadaa90a57ceGemfibrozil
51655-142-262020-01-31C16284748780-19d75b9d0-f8b3-f424-e053-dadaa90a57ceGemfibrozil
51655-142-302020-01-31C16284748780-19d75b9d0-f8b3-f424-e053-dadaa90a57ceGemfibrozil

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GEMFIBROZILACTIVE INGREDIENTQ8X02027X3GEMFIBROZIL TABLET [NORTHWIND PHARMACEUTICALS, LLC]2
GEMFIBROZILACTIVE MOIETYQ8X02027X3GEMFIBROZIL TABLET [NORTHWIND PHARMACEUTICALS, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-142GEMFIBROZIL TABLET [NORTHWIND PHARMACEUTICALS, LLC]2Legacy NDC20150402_5d386c38-7522-41a2-abcf-bd27b737286c.zip