ezetimibe

Product NDC
70771-1109
11-digit product format
707711109
Labeler code
70771
Product ID
70771-1109_5862da1c-e73d-44ff-a961-aaef469ed646
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ezetimibe
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA204331
Marketing category
ANDA
Marketing start
2017-08-09
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
70771-1109-0ezetimibe1000 in 1 BOTTLETABLET10005
70771-1109-1ezetimibe100 in 1 BOTTLETABLET1005
70771-1109-2ezetimibe10 in 1 BLISTER PACKTABLET105
70771-1109-3ezetimibe30 in 1 BOTTLETABLET305
70771-1109-4ezetimibe10 in 1 CARTONTABLET105
70771-1109-5ezetimibe500 in 1 BOTTLETABLET5005
70771-1109-9ezetimibe90 in 1 BOTTLETABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1109EZETIMIBE TABLET [ZYDUS LIFESCIENCES LIMITED]5Current NDC, Legacy NDC, 7 package rows20241201_de814dcd-4759-4e9c-a650-335fb885a79d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349556ezetimibe 10 MG Oral TabletPSNde814dcd-4759-4e9c-a650-335fb885a79d5
349556ezetimibe 10 MG Oral TabletSCDde814dcd-4759-4e9c-a650-335fb885a79d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1109-0707711109001000 TABLET in 1 BOTTLE (70771-1109-0) 1000 tablet2017-08-090000-00-00NoNoCurrent
70771-1109-170771110901100 TABLET in 1 BOTTLE (70771-1109-1) 100 tablet2017-08-090000-00-00NoNoCurrent
70771-1109-27077111090210 in 1 BLISTER PACKHistorical
70771-1109-37077111090330 TABLET in 1 BOTTLE (70771-1109-3) 30 tablet2017-08-090000-00-00NoNoCurrent
70771-1109-47077111090410 BLISTER PACK in 1 CARTON (70771-1109-4) / 10 TABLET in 1 BLISTER PACK (70771-1109-2) 10 blister pack2017-08-090000-00-00NoNoCurrent
70771-1109-570771110905500 TABLET in 1 BOTTLE (70771-1109-5) 500 tablet2017-08-090000-00-00NoNoCurrent
70771-1109-97077111090990 TABLET in 1 BOTTLE (70771-1109-9) 90 tablet2017-08-090000-00-00NoNoCurrent