amlodipine and valsartan (68180-764)

Drug Facts

Product Profile

Brand Name amlodipine and valsartan

Generic Name amlodipine and valsartan

Labeler lupin pharmaceuticals, inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

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

Manufacturer

Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-764

Product ID 68180-764_e0777a79-35ef-4f69-b6ac-94d31f7ca6fb

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA090245

Listing Expiration 2026-12-31

Marketing Start 2015-03-31

Pharmacologic Class

Established (EPC)

angiotensin 2 receptor blocker [epc]

Mechanism of Action

angiotensin 2 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68180764

Hyphenated Format 68180-764

Supplemental Identifiers

RxCUI

722126 722131 722134 722137

UPC

0368180765110 0368180766117 0368180767114 0368180764113

UNII

864V2Q084H 80M03YXJ7I

NUI

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 and valsartan (source: ndc)

Generic Name amlodipine and valsartan (source: ndc)

Application Number ANDA090245 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

5 mg/1
160 mg/1

source: ndc

Packaging

16 HOW SUPPLIED/STORAGE AND HANDLING Amlodipine and Valsartan is available as tablets containing amlodipine besylate (6.9 mg or 13.9 mg, equivalent to 5 mg, or 10 mg of amlodipine respectively) with valsartan 160 mg or 320 mg, providing for the following available combinations: 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg. All strengths are packaged in bottles of 30, 90 and 500 count, and unit dose blister packages. 5/160 mg Tablets - Mustard coloured, capsule shaped, film coated, biconvex tablets debossed 'LU' on one side and 'Q12' on the other side. Bottles of 30 NDC # 68180-764-06 Bottles of 90 NDC # 68180-764-09 Bottles of 500 NDC # 68180-764-02 Unit Dose 100 tablets (10 X 10 tablets blister cards) NDC # 68180-764-13 10/160 mg Tablets - Yellow, capsule shaped, film coated, biconvex tablets debossed 'LU' on one side and 'Q14' on the other side. Bottles of 30 NDC # 68180-765-06 Bottles of 90 NDC # 68180-765-09 Bottles of 500 NDC # 68180-765-02 Unit Dose 100 tablets (10 X 10 tablets blister cards) NDC # 68180-765-13 5/320 mg Tablets - Mustard coloured, capsule shaped, film coated, biconvex tablets debossed 'LU' on one side and 'Q13' on the other side. Bottles of 30 NDC # 68180-766-06 Bottles of 90 NDC # 68180-766-09 Bottles of 500 NDC # 68180-766-02 Unit Dose 100 tablets (10 X 10 tablets blister cards) NDC # 68180-766-13 10/320 mg Tablets - Yellow, capsule shaped, film coated, biconvex tablets debossed 'LU' on one side and 'Q15' on the other side Bottles of 30 NDC # 68180-767-06 Bottles of 90 NDC # 68180-767-09 Bottles of 500 NDC # 68180-767-02 Unit Dose 100 tablets (10 X 10 tablets blister cards) NDC # 68180-767-13 Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted between 15°C and 30ºC (59ºF and 86ºF) [See USP Controlled Room Temperature]. Protect from moisture.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Strength: 5/160 mg Tablets Container Label: 30s Pack NDC 68180-764-06 Strength: 5/160 mg Tablets Carton Label: 100 Tablets NDC 68180-764-13 Strength: 5/160 mg Tablets NDC 68180-764-11 Blister strip of 10's Strength: 10/160 mg Tablets Container Label: 30s Pack NDC 68180-765-06 Strength: 10/160 mg Tablets Carton Label: 100 Tablets NDC 68180-765-13 Strength: 10/160 mg Tablets NDC 68180-765-11 Blister strip of 10's Strength: 5/320 mg Tablets Container Label: 30s Pack NDC 68180-766-06 Strength: 5/320 mg Tablets Carton Label: 100 Tablets NDC 68180-766-13 Strength: 5/320 mg Tablets NDC 68180-766-11 Blister strip of 10's Strength: 10/320 mg Tablets Container Label: 30s Pack NDC 68180-767-06 Strength: 10/320 mg Tablets Carton Label: 100 Tablets NDC 68180-767-13 Strength: 10/320 mg Tablets NDC 68180-767-11 Blister strip of 10's 07 08 08 09 09 10 11 12 13 13 14 15

source: label

Packages (0)

No package records.

Ingredients (2)

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

Linked Drug Pages (1)

Amlodipine and Valsartan ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "e0777a79-35ef-4f69-b6ac-94d31f7ca6fb", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0368180765110", "0368180766117", "0368180767114", "0368180764113"], "unii": ["864V2Q084H", "80M03YXJ7I"], "rxcui": ["722126", "722131", "722134", "722137"], "spl_set_id": ["35086164-bf92-4b3c-9845-f8cd7464c7d6"], "pharm_class_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 and Valsartan", "product_id": "68180-764_e0777a79-35ef-4f69-b6ac-94d31f7ca6fb", "dosage_form": "TABLET", "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]"], "product_ndc": "68180-764", "generic_name": "Amlodipine and Valsartan", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amlodipine and Valsartan", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "5 mg/1"}, {"name": "VALSARTAN", "strength": "160 mg/1"}], "application_number": "ANDA090245", "marketing_category": "ANDA", "marketing_start_date": "20150331", "listing_expiration_date": "20261231"}