IRBESARTAN

Product NDC
72189-205
11-digit product format
721890205
Labeler code
72189
Product ID
72189-205_2c290c08-d35e-21b4-e063-6394a90a73b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IRBESARTAN
Dosage form
TABLET
Route
ORAL
Labeler
direct rx
Application
ANDA202910
Marketing category
ANDA
Marketing start
2021-04-21
Substance
IRBESARTAN
Active strength
150 mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
IRBESARTAN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IRBESARTAN150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ0E2756Z7N
Rxcui200094, 200095, 200096

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-205-907218902059090 TABLET in 1 BOTTLE (72189-205-90) 90 tablet2021-04-210000-00-00NoNoCurrent