FDA.reportPublic FDA data

Azilsartan Medoxomil

Product NDC
52536-004
11-digit product format
525360004
Labeler code
52536
Product ID
52536-004_c09103d8-c094-473d-a303-bbb4f334aa8c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azilsartan kamedoxomil
Dosage form
TABLET
Route
ORAL
Labeler
Wilshire Pharmaceuticals, Inc.
Application
NDA200796
Marketing category
NDA
Marketing start
2026-04-27
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
52536-004-03Azilsartan Medoxomil30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52536-004-03EA - Each52536-00445eccbf2-3bc2-415d-9d7d-69682848a36512026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1091646azilsartan medoxomil 40 MG Oral TabletPSNc09103d8-c094-473d-a303-bbb4f334aa8c1
1091652azilsartan medoxomil 80 MG Oral TabletPSNc09103d8-c094-473d-a303-bbb4f334aa8c1
1091646azilsartan medoxomil 40 MG Oral TabletSCDc09103d8-c094-473d-a303-bbb4f334aa8c1
1091652azilsartan medoxomil 80 MG Oral TabletSCDc09103d8-c094-473d-a303-bbb4f334aa8c1
1091646azilsartan medoxomil 40 MG (equivalent to azilsartan kamedoxomil 42.68 MG) Oral TabletSYc09103d8-c094-473d-a303-bbb4f334aa8c1
1091652azilsartan medoxomil 80 MG (equivalent to azilsartan kamedoxomil 85.36 MG) Oral TabletSYc09103d8-c094-473d-a303-bbb4f334aa8c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
52536-004-035253600040330 TABLET in 1 BOTTLE (52536-004-03) 30 tablet2026-04-27NoNoHistorical