FDA.reportPublic FDA data

GEMFIBROZIL

Product NDC
42806-260
11-digit product format
428060260
Labeler code
42806
Product ID
42806-260_e33e6a91-1c1d-4692-b3fb-1ac5776d480b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GEMFIBROZIL
Dosage form
TABLET
Route
ORAL
Labeler
Epic Pharma, LLC
Application
ANDA078012
Marketing category
ANDA
Marketing start
2017-03-23
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
931dfe50-414f-e1ab-9c88-b15c4ba31929Product name520210615
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42806-260-052025-07-29C16284748780-13b156c62-2780-fb37-e063-e6dba90a4e07Gemfibrozil Tablets, USP Rx Only
42806-260-182025-07-29C16284748780-13b156c62-2780-fb37-e063-e6dba90a4e07Gemfibrozil Tablets, USP Rx Only
42806-260-602025-07-29C16284748780-13b156c62-2780-fb37-e063-e6dba90a4e07Gemfibrozil Tablets, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42806-260-05GEMFIBROZIL500 in 1 BOTTLETABLET5009
42806-260-18GEMFIBROZIL180 in 1 BOTTLETABLET1809
42806-260-60GEMFIBROZIL60 in 1 BOTTLETABLET609

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-260-05EA - Each42806-2609b45f163-be15-4533-8925-309d44a72c2512017-04-05
42806-260-60EA - Each42806-260ff661830-e2ed-44d4-9240-058ad1ce094312017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-260GEMFIBROZIL TABLET [EPIC PHARMA, LLC]9Legacy NDC, 3 package rows20231228_77bb947a-340c-4592-b56d-bc77fb17e753.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310459gemfibrozil 600 MG Oral TabletPSN77bb947a-340c-4592-b56d-bc77fb17e7539
310459gemfibrozil 600 MG Oral TabletSCD77bb947a-340c-4592-b56d-bc77fb17e7539
310459gemfibrozil 600 MG Oral TabletPSN2cb2de4d-8261-46d8-ae63-c572fdc887d47
310459gemfibrozil 600 MG Oral TabletSCD2cb2de4d-8261-46d8-ae63-c572fdc887d47
310459gemfibrozil 600 MG Oral TabletPSN991b0066-ffdc-4ca5-8aa1-15674bcdedd11
310459gemfibrozil 600 MG Oral TabletSCD991b0066-ffdc-4ca5-8aa1-15674bcdedd11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42806-260-0542806026005500 TABLET in 1 BOTTLE (42806-260-05) 500 tablet2017-03-230000-00-00NoNoCurrent
42806-260-1842806026018180 TABLET in 1 BOTTLE (42806-260-18) 180 tablet2017-03-230000-00-00NoNoCurrent
42806-260-604280602606060 TABLET in 1 BOTTLE (42806-260-60) 60 tablet2017-03-230000-00-00NoNoCurrent