NDC 0781-5771

AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE

Amlodipine Valsartan And Hydrochlorothiazide

AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc. The primary component is Amlodipine Besylate; Valsartan; Hydrochlorothiazide.

• Product ID: 0781-5771_07a597a4-a78e-4558-adda-335d316400a2
• NDC: 0781-5771
• Product Type: Human Prescription Drug
• Proprietary Name: AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE
• Generic Name: Amlodipine Valsartan And Hydrochlorothiazide
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2014-12-01
• Marketing End Date: 2021-05-31
• Marketing Category: NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
• Application Number: NDA022314
• Labeler Name: Sandoz Inc
• Substance Name: AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE
• Active Ingredient Strength: 5 mg/1; mg/1; mg/1
• Pharm Classes: Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
• NDC Exclude Flag: N

Packaging

NDC 0781-5771-31

30 TABLET, FILM COATED in 1 BOTTLE (0781-5771-31)

• Marketing Start Date: 2014-12-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0781-5771-31 [00781577131]

AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE TABLET, FILM COATED

• Marketing Category: NDA authorized generic
• Application Number: NDA022314
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-12-01
• Marketing End Date: 2018-11-30

Drug Details

Active Ingredients

Ingredient	Strength
AMLODIPINE BESYLATE	5 mg/1

OpenFDA Data

• SPL SET ID: dd311bf0-c5c8-4f0b-9f8f-e855bb32a71e
• Manufacturer:
  • Sandoz Inc
• UNII:
  • 864V2Q084H
  • 0J48LPH2TH
  • 80M03YXJ7I
• RxNorm Concept Unique ID - RxCUI:
  • 848151
  • 848145
  • 848131
  • 848140
  • 848135

Pharmacological Class

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

NDC Crossover Matching brand name "AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE" or generic name "Amlodipine Valsartan And Hydrochlorothiazide"

NDC	Brand Name	Generic Name
0781-5756	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE	amlodipine valsartan and hydrochlorothiazide
0781-5760	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE	amlodipine valsartan and hydrochlorothiazide
0781-5771	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE	amlodipine valsartan and hydrochlorothiazide
0781-5787	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE	amlodipine valsartan and hydrochlorothiazide
0781-5794	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE	amlodipine valsartan and hydrochlorothiazide
49884-175	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE
49884-172	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE
49884-185	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE
49884-174	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE
49884-173	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE
0078-0559	Exforge HCT	amlodipine valsartan and hydrochlorothiazide
0078-0560	Exforge HCT	amlodipine valsartan and hydrochlorothiazide
0078-0561	Exforge HCT	amlodipine valsartan and hydrochlorothiazide
0078-0562	Exforge HCT	amlodipine valsartan and hydrochlorothiazide
0078-0563	Exforge HCT	amlodipine valsartan and hydrochlorothiazide