valsartan and hydrochlorothiazide

Generic: valsartan and hydrochlorothiazide

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valsartan and hydrochlorothiazide
Generic Name valsartan and hydrochlorothiazide
Labeler amneal pharmaceuticals llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

hydrochlorothiazide 12.5 mg/1, valsartan 320 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-848
Product ID 65162-848_e40f4475-c8d3-48a6-913f-cf7c8c7b119b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204382
Listing Expiration 2026-12-31
Marketing Start 2023-08-14

Pharmacologic Class

Established (EPC)
thiazide diuretic [epc] angiotensin 2 receptor blocker [epc]
Mechanism of Action
angiotensin 2 receptor antagonists [moa]
Chemical Structure
thiazides [cs]
Physiologic Effect
increased diuresis [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162848
Hyphenated Format 65162-848

Supplemental Identifiers

RxCUI
200284 200285 349353 636042 636045
UPC
0365162849097 0365162847093 0365162846096 0365162848090
UNII
0J48LPH2TH 80M03YXJ7I
NUI
N0000175359 N0000175419 M0471776 N0000000070 N0000175561

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name valsartan and hydrochlorothiazide (source: ndc)
Generic Name valsartan and hydrochlorothiazide (source: ndc)
Application Number ANDA204382 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
  • 320 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (65162-848-03)
  • 90 TABLET, FILM COATED in 1 BOTTLE (65162-848-09)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (65162-848-11)
  • 500 TABLET, FILM COATED in 1 BOTTLE (65162-848-50)
source: ndc

Packages (4)

65162-848-03 30 TABLET, FILM COATED in 1 BOTTLE (65162-848-03) 65162-848-09 90 TABLET, FILM COATED in 1 BOTTLE (65162-848-09) 65162-848-11 1000 TABLET, FILM COATED in 1 BOTTLE (65162-848-11) 65162-848-50 500 TABLET, FILM COATED in 1 BOTTLE (65162-848-50)

Ingredients (2)

hydrochlorothiazide (12.5 mg/1) valsartan (320 mg/1)

Linked Drug Pages (1)

Valsartan and Hydrochlorothiazide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e40f4475-c8d3-48a6-913f-cf7c8c7b119b", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000000070", "N0000175561"], "upc": ["0365162849097", "0365162847093", "0365162846096", "0365162848090"], "unii": ["0J48LPH2TH", "80M03YXJ7I"], "rxcui": ["200284", "200285", "349353", "636042", "636045"], "spl_set_id": ["c9acbc95-3629-4276-842b-5c074844dba7"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]", "Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65162-848-03)", "package_ndc": "65162-848-03", "marketing_start_date": "20230814"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (65162-848-09)", "package_ndc": "65162-848-09", "marketing_start_date": "20230814"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (65162-848-11)", "package_ndc": "65162-848-11", "marketing_start_date": "20230814"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65162-848-50)", "package_ndc": "65162-848-50", "marketing_start_date": "20230814"}], "brand_name": "Valsartan and Hydrochlorothiazide", "product_id": "65162-848_e40f4475-c8d3-48a6-913f-cf7c8c7b119b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]", "Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "65162-848", "generic_name": "Valsartan and Hydrochlorothiazide", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valsartan and Hydrochlorothiazide", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "12.5 mg/1"}, {"name": "VALSARTAN", "strength": "320 mg/1"}], "application_number": "ANDA204382", "marketing_category": "ANDA", "marketing_start_date": "20230814", "listing_expiration_date": "20261231"}