Azilsartan medoxomil

Product NDC
70748-236
11-digit product format
707480236
Labeler code
70748
Product ID
70748-236_f05aba4d-376f-460f-9264-ecf267e04dcd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azilsartan medoxomil
Dosage form
TABLET
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA214489
Marketing category
ANDA
Marketing start
2026-05-14
Substance
AZILSARTAN KAMEDOXOMIL
Active strength
40 mg/1
Pharmacologic classes
Angiotensin 2 Receptor Blocker [EPC], Angiotensin 2 Type 1 Receptor Antagonists [MoA], Decreased Blood Pressure [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Azilsartan medoxomil
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZILSARTAN KAMEDOXOMIL40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui1091646, 1091652

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0450926f-f624-49c2-83be-42807e8fbcd5Product name120251113
9c73251d-aa60-4cfe-993e-64d90dc1df32Product name120201015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70748-236-06Azilsartan medoxomil30 in 1 BOTTLETABLET307

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1091646azilsartan medoxomil 40 MG Oral TabletPSNb1c8de43-3b26-408f-8c7e-6c7d763481997
1091652azilsartan medoxomil 80 MG Oral TabletPSNb1c8de43-3b26-408f-8c7e-6c7d763481997
1091646azilsartan medoxomil 40 MG Oral TabletSCDb1c8de43-3b26-408f-8c7e-6c7d763481997
1091652azilsartan medoxomil 80 MG Oral TabletSCDb1c8de43-3b26-408f-8c7e-6c7d763481997
1091646azilsartan medoxomil 40 MG (equivalent to azilsartan kamedoxomil 42.68 MG) Oral TabletSYb1c8de43-3b26-408f-8c7e-6c7d763481997
1091652azilsartan medoxomil 80 MG (equivalent to azilsartan kamedoxomil 85.36 MG) Oral TabletSYb1c8de43-3b26-408f-8c7e-6c7d763481997

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70748-236-067074802360630 TABLET in 1 BOTTLE (70748-236-06) 30 tablet2026-05-14NoNoCurrent