valsartan and hydrochlorothiazide

Generic: valsartan and hydrochlorothiazide

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valsartan and hydrochlorothiazide
Generic Name valsartan and hydrochlorothiazide
Labeler lupin pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

hydrochlorothiazide 12.5 mg/1, valsartan 160 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-104
Product ID 68180-104_537df828-cd82-4b5e-9d0d-da8bd1cfd736
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078946
Listing Expiration 2026-12-31
Marketing Start 2013-03-21

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 68180104
Hyphenated Format 68180-104

Supplemental Identifiers

RxCUI
200284 200285 349353 636042 636045
UPC
0368180105091 0368180103097 0368180104094
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 ANDA078946 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
  • 160 mg/1
source: ndc
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING Valsartan and hydrochlorothiazide tablets USP are available as non-scored tablets containing valsartan/hydrochlorothiazide 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg and 320 mg/25 mg. Strengths are available as follows. 80 mg/12.5 mg Tablet - Light pink colored, capsule shaped, film-coated biconvex tablets, debossed with "LU" on one side and "P11" on the other side. Bottles of 90 NDC 68180-103-09 Bottles of 500 NDC 68180-103-02 Bottles of 1000 NDC 68180-103-03 10 X 10’ Blister Pack NDC 68180-103-13 160 mg/12.5 mg Tablet - Reddish brown colored, capsule shaped, film-coated biconvex tablets, debossed with "LU" on one side and "P12" on the other side. Bottles of 90 NDC 68180-104-09 Bottles of 500 NDC 68180-104-02 Bottles of 1000 NDC 68180-104-03 10 X 10’ Blister Pack NDC 68180-104-13 160 mg/25 mg Tablet - Light orange colored, capsule shaped, film-coated biconvex tablets, debossed with "LU" on one side and "P13" on the other side. Bottles of 90 NDC 68180-105-09 Bottles of 500 NDC 68180-105-02 Bottles of 1000 NDC 68180-105-03 10 X 10’ Blister Pack NDC 68180-105-13 320 mg/12.5 mg Tablet - Pink, capsule shaped, film-coated biconvex tablets, debossed with "LU" on one side and "P14" on the other side. Bottles of 90 NDC 68180-101-09 Bottles of 500 NDC 68180-101-02 10 X 10’ Blister Pack NDC 68180-101-13 320 mg/25 mg Tablet - Yellow, capsule shaped, film-coated biconvex tablets, debossed with 'LU' on one side and 'P15' on the other side. Bottles of 90 NDC 68180-102-09 Bottles of 500 NDC 68180-102-02 10 X 10’ Blister Pack NDC 68180-102-13 Store at 20°C-25°C (68°F-77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP).
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 68180-103-09 VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS USP 80 mg/12.5 mg Rx only Bottle of 90 Tablets NDC 68180-103-11 VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS USP 80 mg/12.5 mg Rx only Blister of 10 Tablets NDC 68180-103-13 VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS USP 80 mg/12.5 mg Rx only Carton of 10 Blisters NDC 68180-104-09 VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS USP 160 mg/12.5 mg Rx only Bottle of 90 Tablets NDC 68180-104-11 VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS USP 160 mg/12.5 mg Rx only Blister of 10 Tablets NDC 68180-104-13 VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS USP 160 mg/12.5 mg Rx only Carton of 10 Blisters NDC 68180-105-09 VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS USP 160 mg/25 mg Rx only Bottle of 90 Tablets NDC 68180-105-11 VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS USP 160 mg/25 mg Rx only Blister of 10 Tablets NDC 68180-105-13 VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS USP 160 mg/25 mg Rx only Carton of 10 Blisters NDC 68180-101-09 VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS USP 320 mg/12.5 mg Rx only Bottle of 90 Tablets NDC 68180-101-11 VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS USP 320 mg/12.5 mg Rx only Blister of 10 Tablets NDC 68180-101-13 VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS USP 320 mg/12.5 mg Rx only Carton of 10 Blisters NDC 68180-102-09 VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS USP 320 mg/25 mg Rx only Bottle of 90 Tablets NDC 68180-102-11 VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS USP 320 mg/25 mg Rx only Blister of 10 Tablets NDC 68180-102-13 VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS USP 320 mg/25 mg Rx only Carton of 10 Blisters image1 image2 image3 image4 image5 image6 image7 image8 image9 image10 image11 image12 image13 image14 image15
source: label

Packages (0)

No package records.

Ingredients (2)

hydrochlorothiazide (12.5 mg/1) valsartan (160 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": "537df828-cd82-4b5e-9d0d-da8bd1cfd736", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000000070", "N0000175561"], "upc": ["0368180105091", "0368180103097", "0368180104094"], "unii": ["0J48LPH2TH", "80M03YXJ7I"], "rxcui": ["200284", "200285", "349353", "636042", "636045"], "spl_set_id": ["d74a85de-5917-401a-b92d-6a95da5d30a6"], "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": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Valsartan and Hydrochlorothiazide", "product_id": "68180-104_537df828-cd82-4b5e-9d0d-da8bd1cfd736", "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": "68180-104", "generic_name": "Valsartan and Hydrochlorothiazide", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valsartan and Hydrochlorothiazide", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "12.5 mg/1"}, {"name": "VALSARTAN", "strength": "160 mg/1"}], "application_number": "ANDA078946", "marketing_category": "ANDA", "marketing_start_date": "20130321", "listing_expiration_date": "20261231"}