valsartan and hydrochlorothiazide

Generic: valsartan and hydrochlorothiazide

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

hydrochlorothiazide 25 mg/1, valsartan 320 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-457
Product ID 46708-457_7fb28413-d2ab-4534-8f12-48ce33bbc6a9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201662
Listing Expiration 2026-12-31
Marketing Start 2016-05-20

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 46708457
Hyphenated Format 46708-457

Supplemental Identifiers

RxCUI
200284 200285 349353 636042 636045
UPC
0346708454302 0346708455309 0346708456306 0346708457303 0346708453305
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 ANDA201662 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 320 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 CARTON (46708-457-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE (46708-457-30)
  • 500 TABLET, FILM COATED in 1 BOTTLE (46708-457-71)
  • 90 TABLET, FILM COATED in 1 BOTTLE (46708-457-90)
source: ndc

Packages (4)

46708-457-10 100 TABLET, FILM COATED in 1 CARTON (46708-457-10) 46708-457-30 30 TABLET, FILM COATED in 1 BOTTLE (46708-457-30) 46708-457-71 500 TABLET, FILM COATED in 1 BOTTLE (46708-457-71) 46708-457-90 90 TABLET, FILM COATED in 1 BOTTLE (46708-457-90)

Ingredients (2)

hydrochlorothiazide (25 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": "7fb28413-d2ab-4534-8f12-48ce33bbc6a9", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000000070", "N0000175561"], "upc": ["0346708454302", "0346708455309", "0346708456306", "0346708457303", "0346708453305"], "unii": ["0J48LPH2TH", "80M03YXJ7I"], "rxcui": ["200284", "200285", "349353", "636042", "636045"], "spl_set_id": ["3b80f726-9e1e-4d44-ad4f-afd10e26292f"], "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": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 CARTON (46708-457-10)", "package_ndc": "46708-457-10", "marketing_start_date": "20160520"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (46708-457-30)", "package_ndc": "46708-457-30", "marketing_start_date": "20160520"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (46708-457-71)", "package_ndc": "46708-457-71", "marketing_start_date": "20160520"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (46708-457-90)", "package_ndc": "46708-457-90", "marketing_start_date": "20160520"}], "brand_name": "Valsartan and Hydrochlorothiazide", "product_id": "46708-457_7fb28413-d2ab-4534-8f12-48ce33bbc6a9", "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": "46708-457", "generic_name": "Valsartan and Hydrochlorothiazide", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valsartan and Hydrochlorothiazide", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "25 mg/1"}, {"name": "VALSARTAN", "strength": "320 mg/1"}], "application_number": "ANDA201662", "marketing_category": "ANDA", "marketing_start_date": "20160520", "listing_expiration_date": "20261231"}