FDA.reportPublic FDA data

Ezetimibe

Product NDC
60429-982
11-digit product format
604290982
Labeler code
60429
Product ID
60429-982_147f2538-e782-57d0-e063-6394a90ab598
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ezetimibe
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA207311
Marketing category
ANDA
Marketing start
2017-06-12
Substance
EZETIMIBE
Active strength
10 mg/1
Pharmacologic classes
Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ezetimibe
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EZETIMIBE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEOR26LQQ24
Rxcui349556

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
93a156a6-903b-1690-4dc3-a57adfaa8c1aProduct name920230322
c8f25656-847a-4de8-96a7-06bf98d83c2bProduct name120210916
b249faa8-b784-47ef-8ad4-031ef248fa73Product name120200626
c4422d73-8e69-1539-606a-32a25fa00ebcProduct name420190926
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60429-982-05Ezetimibe500 in 1 BOTTLETABLET5007
60429-982-30Ezetimibe30 in 1 BOTTLETABLET307
60429-982-90Ezetimibe90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-982-05EA - Each60429-9826370e2fe-7200-4d66-a590-1ef5a8e42a4712017-12-14
60429-982-30EA - Each60429-98299471c18-2dfb-4ca2-953c-a32125855cbd12017-12-14
60429-982-90EA - Each60429-982aa5c5742-e95e-4c9b-ac65-e4d5d00d738512017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60429-982EZETIMIBE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]7Current NDC, Legacy NDC, 3 package rows20240404_4a78aa8d-1fe0-4df0-a15b-2350c15aead1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349556ezetimibe 10 MG Oral TabletPSN4a78aa8d-1fe0-4df0-a15b-2350c15aead17
349556ezetimibe 10 MG Oral TabletSCD4a78aa8d-1fe0-4df0-a15b-2350c15aead17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60429-982-0560429098205500 TABLET in 1 BOTTLE (60429-982-05) 500 tablet2017-11-060000-00-00NoNoCurrent
60429-982-306042909823030 TABLET in 1 BOTTLE (60429-982-30) 30 tablet2017-11-060000-00-00NoNoCurrent
60429-982-906042909829090 TABLET in 1 BOTTLE (60429-982-90) 90 tablet2017-11-060000-00-00NoNoCurrent