Ezetimibe and Simvastatin

Product NDC
60429-879
11-digit product format
604290879
Labeler code
60429
Product ID
60429-879_b0a4f16b-bb52-31d0-e053-2995a90a8b6a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ezetimibe and Simvastatin
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA200909
Marketing category
ANDA
Marketing start
2017-04-26
Marketing end
0000-00-00
Substance
EZETIMIBE; SIMVASTATIN
Active strength
10 mg/1; mg/1
Pharmacologic classes
Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
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
60429-879-10EA - Each60429-8798c282685-ff96-416a-a9bb-0c396061c06812017-06-15
60429-879-30EA - Each60429-879fdadb26c-e8c1-4c86-8598-09175ab3329212017-06-15
60429-879-90EA - Each60429-879216b7be0-22bf-4512-a755-091c90cd724a12017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60429-879EZETIMIBE AND SIMVASTATIN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]8Legacy NDC20220609_2adcaf55-894d-4e7f-85b2-609f9144a572.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60429-879-306042908793030 TABLET in 1 BOTTLE (60429-879-30) 30 tablet2017-04-260000-00-00NoNoCurrent