amlodipine, valsartan and hydrochlorothiazide

Generic: amlodipine, valsartan and hydrochlorothiazide

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

Drug Facts

Product Profile

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

amlodipine besylate 5 mg/1, hydrochlorothiazide 12.5 mg/1, valsartan 160 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-771
Product ID 68180-771_5e938b33-b86d-40ab-b5c5-b7137ef9404d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200797
Listing Expiration 2026-12-31
Marketing Start 2015-06-04

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 68180771
Hyphenated Format 68180-771

Supplemental Identifiers

RxCUI
848131 848135 848140 848145 848151
UNII
0J48LPH2TH 864V2Q084H 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 amlodipine, valsartan and hydrochlorothiazide (source: ndc)
Generic Name amlodipine, valsartan and hydrochlorothiazide (source: ndc)
Application Number ANDA200797 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
  • 12.5 mg/1
  • 160 mg/1
source: ndc
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING Amlodipine, valsartan and hydrochlorothiazide tablets USP, are available as film-coated tablets containing amlodipine besylate equivalent to 5 mg or 10 mg of amlodipine free-base with valsartan 160 mg or 320 mg and hydrochlorothiazide 12.5 mg or 25 mg, providing for the following available combination: 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg, 10/160/25 mg and 10/320/25 mg. All strengths are packaged in bottles of 30, 90 and 500 tablets. Amlodipine, valsartan and hydrochlorothiazide tablets USP, 5 mg/160 mg/12.5 mg – White to off-white, capsule shaped, film coated, biconvex tablets, debossed with 'LU' on one side and 'W41' on the other side. Bottles of 30 NDC 68180-771-06 Bottles of 90 NDC 68180-771-09 Bottles of 500 NDC 68180-771-02 Amlodipine, valsartan and hydrochlorothiazide tablets USP, 10 mg/160 mg/12.5 mg – Mustard colored, capsule shaped, film coated, biconvex tablets, debossed with 'LU' on one side and 'W43' on the other side. Bottles of 30 NDC 68180-772-06 Bottles of 90 NDC 68180-772-09 Bottles of 500 NDC 68180-772-02 Amlodipine, valsartan and hydrochlorothiazide tablets USP, 5 mg/160 mg/25 mg – Yellow colored, capsule shaped, film coated, biconvex tablets, debossed with 'LU' on one side and 'W42' on the other side. Bottles of 30 NDC 68180-773-06 Bottles of 90 NDC 68180-773-09 Bottles of 500 NDC 68180-773-02 Amlodipine, valsartan and hydrochlorothiazide tablets USP, 10 mg/160 mg/25 mg – Beige colored, capsule shaped, film coated, biconvex tablets, debossed with 'LU' on one side and 'W44' on the other side. Bottles of 30 NDC 68180-774-06 Bottles of 90 NDC 68180-774-09 Bottles of 500 NDC 68180-774-02 Amlodipine, valsartan and hydrochlorothiazide tablets USP, 10 mg/320 mg/25 mg – Light brick red colored, capsule shaped, film coated, biconvex tablets, debossed with 'LU' on one side and 'W45' on the other side. Bottles of 30 NDC 68180-775-06 Bottles of 90 NDC 68180-775-09 Bottles of 500 NDC 68180-775-02 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 Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP Rx Only 5 mg/160 mg/12.5 mg NDC 68180-771-06 30 Tablets Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP Rx Only 10 mg/160 mg/12.5 mg NDC 68180-772-06 30 Tablets Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP Rx Only 5 mg/160 mg/25 mg NDC 68180-773-06 30 Tablets Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP Rx Only 10 mg/160 mg/25 mg NDC 68180-774-06 30 Tablets Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP Rx Only 10 mg/320 mg/25 mg NDC 68180-775-06 30 Tablets 09 10 11 12 13
source: label

Packages (0)

No package records.

Ingredients (3)

amlodipine besylate (5 mg/1) hydrochlorothiazide (12.5 mg/1) valsartan (160 mg/1)

Linked Drug Pages (1)

Amlodipine, Valsartan and Hydrochlorothiazide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5e938b33-b86d-40ab-b5c5-b7137ef9404d", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000000070", "N0000175561"], "unii": ["0J48LPH2TH", "864V2Q084H", "80M03YXJ7I"], "rxcui": ["848131", "848135", "848140", "848145", "848151"], "spl_set_id": ["5dbb43b1-3ea4-4fa5-a9aa-95d869ae65fe"], "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": "Amlodipine, Valsartan and Hydrochlorothiazide", "product_id": "68180-771_5e938b33-b86d-40ab-b5c5-b7137ef9404d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]", "Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A Inhibitors [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]", "Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "68180-771", "generic_name": "Amlodipine, Valsartan and Hydrochlorothiazide", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amlodipine, Valsartan and Hydrochlorothiazide", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "5 mg/1"}, {"name": "HYDROCHLOROTHIAZIDE", "strength": "12.5 mg/1"}, {"name": "VALSARTAN", "strength": "160 mg/1"}], "application_number": "ANDA200797", "marketing_category": "ANDA", "marketing_start_date": "20150604", "listing_expiration_date": "20261231"}