Gemfibrozil

Product NDC
70934-466
11-digit product format
709340466
Labeler code
70934
Product ID
70934-466_a7aca074-ff60-59aa-e053-2a95a90aef61
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gemfibrozil
Dosage form
TABLET
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA203266
Marketing category
ANDA
Marketing start
2019-11-26
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-466-30EA - Each70934-466c1aa258c-c8ac-4c29-a856-f54ca69c682612022-12-07
70934-466-60EA - Each70934-466c7c4b7e3-d056-42b5-9a96-012a86f6859212022-12-07
70934-466-90EA - Each70934-4669d69c4df-add8-4b61-93dd-06cd6f0f246012021-10-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-466-307093404663030 TABLET in 1 BOTTLE, PLASTIC (70934-466-30) 30 tablet2020-03-260000-00-00NoNoCurrent
70934-466-607093404666060 TABLET in 1 BOTTLE, PLASTIC (70934-466-60) 60 tablet2020-05-190000-00-00NoNoCurrent
70934-466-907093404669090 TABLET in 1 BOTTLE, PLASTIC (70934-466-90) 90 tablet2019-11-260000-00-00NoNoCurrent