NDC 0024-5856

Avalide

Irbesartan And Hydrochlorothiazide

Avalide is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Sanofi-aventis U.s. Llc. The primary component is Irbesartan; Hydrochlorothiazide.

• Product ID: 0024-5856_18162dad-7813-4074-b159-d94ce6bb5fca
• NDC: 0024-5856
• Product Type: Human Prescription Drug
• Proprietary Name: Avalide
• Generic Name: Irbesartan And Hydrochlorothiazide
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2013-01-01
• Marketing Category: NDA / NDA
• Application Number: NDA020758
• Labeler Name: sanofi-aventis U.S. LLC
• Substance Name: IRBESARTAN; HYDROCHLOROTHIAZIDE
• Active Ingredient Strength: 300 mg/1; mg/1
• Pharm Classes: Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0024-5856-30

30 TABLET, FILM COATED in 1 BOTTLE (0024-5856-30)

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

NDC SPL Data Element Entries

NDC 0024-5856-90 [00024585690]

Avalide TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020758
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-01-01
• Marketing End Date: 2016-08-31

NDC 0024-5856-30 [00024585630]

Avalide TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020758
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-01-01

Drug Details

Active Ingredients

Ingredient	Strength
IRBESARTAN	300 mg/1

OpenFDA Data

• SPL SET ID: 0d91895e-c869-4b33-9b83-d55c1ad6317e
• Manufacturer:
  • sanofi-aventis U.S. LLC
• UNII:
  • J0E2756Z7N
  • 0J48LPH2TH
• RxNorm Concept Unique ID - RxCUI:
  • 310792
  • 310793
  • 823938
  • 823934

Pharmacological Class

• Angiotensin 2 Receptor Antagonists [MoA]
• Angiotensin 2 Receptor Blocker [EPC]
• Increased Diuresis [PE]
• Thiazide Diuretic [EPC]
• Thiazides [CS]

NDC Crossover Matching brand name "Avalide" or generic name "Irbesartan And Hydrochlorothiazide"

NDC	Brand Name	Generic Name
0024-5855	Avalide	irbesartan and hydrochlorothiazide
0024-5856	Avalide	irbesartan and hydrochlorothiazide
0054-0254	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide
0054-0255	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide
0093-8232	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide
0093-8238	Irbesartan and Hydrochlorothiazide	Irbesartan and Hydrochlorothiazide
0955-1045	Irbesartan and Hydrochlorothiazide	irbesartan and hydrochlorothiazide
0955-1046	Irbesartan and Hydrochlorothiazide	irbesartan and hydrochlorothiazide