FDA.reportPublic FDA data

Ezetimibe

Product NDC
0904-7103
11-digit product format
009047103
Labeler code
0904
Product ID
0904-7103_ca6fb267-ef29-4912-a10a-75f2613014f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ezetimibe
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA209234
Marketing category
ANDA
Marketing start
2017-12-23
Marketing end
2027-08-31
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ezetimibe

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
0904-7103-04Ezetimibe1 in 1 BLISTER PACKTABLET17
0904-7103-04Ezetimibe30 in 1 CARTONTABLET307
0904-7103-10Ezetimibe20 in 1 CARTONTABLET207
0904-7103-10Ezetimibe1 in 1 BLISTER PACKTABLET17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7103-04EA - Each0904-7103bba0b232-97a0-456f-8f07-5e368e5dfc2712021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7103EZETIMIBE TABLET [MAJOR PHARMACEUTICALS]5Current NDC, Legacy NDC, 4 package rows20241212_e257ed7f-5015-4f1d-93f4-5adf5797643d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349556ezetimibe 10 MG Oral TabletPSNe257ed7f-5015-4f1d-93f4-5adf5797643d7
349556ezetimibe 10 MG Oral TabletSCDe257ed7f-5015-4f1d-93f4-5adf5797643d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7103-040090471030430 BLISTER PACK in 1 CARTON (0904-7103-04) / 1 TABLET in 1 BLISTER PACK30 blister pack2017-12-232027-03-31NoNoCurrent
0904-7103-100090471031020 BLISTER PACK in 1 CARTON (0904-7103-10) / 1 TABLET in 1 BLISTER PACK20 blister pack2023-08-252027-08-31NoNoHistorical