FDA.reportPublic FDA data

Zetia

Product NDC
21695-778
11-digit product format
216950778
Labeler code
21695
Product ID
21695-778_582e1593-1e6c-4ce8-8bae-134fbc3a66f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ezetimibe
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA021445
Marketing category
NDA
Marketing start
2009-07-27
Marketing end
0000-00-00
Substance
EZETIMIBE
Active strength
10 mg/1
Pharmacologic classes
Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-778-302019-09-24C16284748780-1934fe258-4a88-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use ZETIA safely and effectively. See full prescribing information for ZETIA. ZETIA (ezetimibe) Tablets Initial U.S. Approval: 2002
21695-778-902019-09-24C16284748780-1934fe258-4a88-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use ZETIA safely and effectively. See full prescribing information for ZETIA. ZETIA (ezetimibe) Tablets Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-778-30Zetia30 in 1 BOTTLETABLET301
21695-778-90Zetia90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-778-30EA - Each21695-77876f7d438-8298-43ea-ad1f-63cc5995fd5312012-07-24
21695-778-90EA - Each21695-7782d950d7c-0ea3-469a-82df-b253e6e9502e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EzetimibeACTIVE INGREDIENTEOR26LQQ24ZETIA (EZETIMIBE) TABLET [REBEL DISTRIBUTORS CORP]1
EzetimibeACTIVE MOIETYEOR26LQQ24ZETIA (EZETIMIBE) TABLET [REBEL DISTRIBUTORS CORP]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UZETIA (EZETIMIBE) TABLET [REBEL DISTRIBUTORS CORP]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48ZETIA (EZETIMIBE) TABLET [REBEL DISTRIBUTORS CORP]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XZETIA (EZETIMIBE) TABLET [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30ZETIA (EZETIMIBE) TABLET [REBEL DISTRIBUTORS CORP]1
povidoneINACTIVE INGREDIENTFZ989GH94EZETIA (EZETIMIBE) TABLET [REBEL DISTRIBUTORS CORP]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JZETIA (EZETIMIBE) TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-778ZETIA (EZETIMIBE) TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20110622_582e1593-1e6c-4ce8-8bae-134fbc3a66f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349556ezetimibe 10 MG Oral TabletPSN582e1593-1e6c-4ce8-8bae-134fbc3a66f01
352304Zetia 10 MG Oral TabletPSN582e1593-1e6c-4ce8-8bae-134fbc3a66f01
352304ezetimibe 10 MG Oral Tablet [Zetia]SBD582e1593-1e6c-4ce8-8bae-134fbc3a66f01
349556ezetimibe 10 MG Oral TabletSCD582e1593-1e6c-4ce8-8bae-134fbc3a66f01
352304Zetia 10 MG Oral TabletSY582e1593-1e6c-4ce8-8bae-134fbc3a66f01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-778-302169507783030 in 1 BOTTLEHistorical
21695-778-902169507789090 in 1 BOTTLEHistorical