NDC 61919-790

VALSARTAN/HTCZ

Valsartan/htcz

VALSARTAN/HTCZ is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Directrx. The primary component is Hydrochlorothiazide; Valsartan.

• Product ID: 61919-790_861b145f-ede1-cb0f-e053-2991aa0aa34d
• NDC: 61919-790
• Product Type: Human Prescription Drug
• Proprietary Name: VALSARTAN/HTCZ
• Generic Name: Valsartan/htcz
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-04-09
• Marketing Category: ANDA / ANDA
• Application Number: ANDA203145
• Labeler Name: DIRECTRX
• Substance Name: HYDROCHLOROTHIAZIDE; VALSARTAN
• Active Ingredient Strength: 13 mg/1; mg/1
• Pharm Classes: Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 61919-790-30

30 TABLET, FILM COATED in 1 BOTTLE (61919-790-30)

• Marketing Start Date: 2019-04-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61919-790-30 [61919079030]

VALSARTAN/HTCZ TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA203145
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-04-09

Drug Details

Active Ingredients

Ingredient	Strength
HYDROCHLOROTHIAZIDE	12.5 mg/1

OpenFDA Data

• SPL SET ID: 861b145f-ede0-cb0f-e053-2991aa0aa34d
• Manufacturer:
  • DIRECTRX
• UNII:
  • 0J48LPH2TH
  • 80M03YXJ7I

Pharmacological Class

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