NDC 0024-5852

Avapro

Irbesartan

Avapro is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Sanofi-aventis U.s. Llc. The primary component is Irbesartan.

• Product ID: 0024-5852_07fb6e5f-7a79-499f-8396-b577ef1838d5
• NDC: 0024-5852
• Product Type: Human Prescription Drug
• Proprietary Name: Avapro
• Generic Name: Irbesartan
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2013-01-01
• Marketing Category: NDA / NDA
• Application Number: NDA020757
• Labeler Name: sanofi-aventis U.S. LLC
• Substance Name: IRBESARTAN
• Active Ingredient Strength: 300 mg/1
• Pharm Classes: Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0024-5852-30

30 TABLET, FILM COATED in 1 BOTTLE (0024-5852-30)

• Marketing Start Date: 2013-01-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0024-5852-30 [00024585230]

Avapro TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020757
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-01-01

NDC 0024-5852-90 [00024585290]

Avapro TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020757
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-01-01
• Marketing End Date: 2016-06-30

Drug Details

Active Ingredients

Ingredient	Strength
IRBESARTAN	300 mg/1

OpenFDA Data

• SPL SET ID: 7885b2a8-be4e-48ab-8113-4e6ab791eb98
• Manufacturer:
  • sanofi-aventis U.S. LLC
• UNII:
  • J0E2756Z7N
• RxNorm Concept Unique ID - RxCUI:
  • 200096
  • 200095
  • 200094
  • 153665
  • 153667
  • 153666

Pharmacological Class

• Angiotensin 2 Receptor Antagonists [MoA]
• Angiotensin 2 Receptor Blocker [EPC]

NDC Crossover Matching brand name "Avapro" or generic name "Irbesartan"

NDC	Brand Name	Generic Name
0024-5850	Avapro	irbesartan
0024-5851	Avapro	irbesartan
0024-5852	Avapro	irbesartan
35356-854	Avapro	Avapro
0054-0250	Irbesartan	Irbesartan
0054-0251	Irbesartan	Irbesartan
0054-0252	Irbesartan	Irbesartan
0955-1040	Irbesartan	irbesartan
0955-1041	Irbesartan	irbesartan
0955-1042	Irbesartan	irbesartan