Ezetimibe and Simvastatin

Product NDC
60429-880
11-digit product format
604290880
Labeler code
60429
Product ID
60429-880_e0e32c41-be29-311c-e053-2995a90a7cd7
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-880-10EA - Each60429-8800e47c2b5-20c6-47a8-bfdf-cad98b19be2a12017-06-15
60429-880-30EA - Each60429-88049995eda-6b65-4b14-90c9-c3950d56d48012017-06-15
60429-880-90EA - Each60429-880277e9766-53ba-4cfc-b835-3f190020067412017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60429-880EZETIMIBE 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
60429-880-906042908809090 TABLET in 1 BOTTLE (60429-880-90) 90 tablet2017-04-260000-00-00NoNoCurrent