Irbesartan

Product NDC: 71335-1547
11-digit product format: 713351547
Labeler code: 71335
Product ID: 71335-1547_a542837c-0c20-46b9-8c08-f10acad8fc38
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Irbesartan
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA202910
Marketing category: ANDA
Marketing start: 2012-09-27
Substance: IRBESARTAN
Active strength: 75 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

openFDA Listing Details

Product ID: 71335-1547_a542837c-0c20-46b9-8c08-f10acad8fc38
SPL ID: a542837c-0c20-46b9-8c08-f10acad8fc38
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: Irbesartan
Generic name: Irbesartan
Dosage form: TABLET
Route: ORAL
Marketing start: 2012-09-27
Marketing category: ANDA
Application number: ANDA202910
Pharmacologic classes: Angiotensin 2 Receptor Antagonists [MoA]; Angiotensin 2 Receptor Blocker [EPC]
Listing expiration: 2026-12-31

Ingredient	Strength
IRBESARTAN	75 mg/1

Package NDC	Description	Marketing start	Sample
71335-1547-1	30 TABLET in 1 BOTTLE (71335-1547-1)	2020-03-30	No
71335-1547-2	90 TABLET in 1 BOTTLE (71335-1547-2)	2020-03-30	No

UNII	Preferred term	Registry number	Matched term
J0E2756Z7N	IRBESARTAN	138402-11-6	IRBESARTAN

Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71335-1547-1	71335154701	30 TABLET in 1 BOTTLE (71335-1547-1)	30 tablet	2020-03-30	No	No	Historical
71335-1547-2	71335154702	90 TABLET in 1 BOTTLE (71335-1547-2)	90 tablet	2020-03-30	No	No	Historical

Title	Manufacturer	Effective date	Type	Version
Irbesartan	Bryant Ranch Prepack	2024-04-03	HUMAN PRESCRIPTION DRUG LABEL	3