amlodipine besylate and benazepril hydrochloride

Generic: amlodipine besylate and benazepril hydrochloride

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

Drug Facts

Product Profile

Brand Name amlodipine besylate and benazepril hydrochloride
Generic Name amlodipine besylate and benazepril hydrochloride
Labeler lupin pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

amlodipine besylate 10 mg/1, benazepril hydrochloride 20 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-758
Product ID 68180-758_53566d4f-ff40-4815-b922-3416cde56fb1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078466
Listing Expiration 2026-12-31
Marketing Start 2010-02-05

Pharmacologic Class

Classes
angiotensin converting enzyme inhibitor [epc] angiotensin-converting enzyme inhibitors [moa] calcium channel antagonists [moa] calcium channel blocker [epc] cytochrome p450 3a inhibitors [moa] decreased blood pressure [pe] dihydropyridine calcium channel blocker [epc] dihydropyridines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68180758
Hyphenated Format 68180-758

Supplemental Identifiers

RxCUI
898342 898346 898350 898353 898356 898359
UPC
0368180459019
UNII
864V2Q084H N1SN99T69T

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 besylate and benazepril hydrochloride (source: ndc)
Generic Name amlodipine besylate and benazepril hydrochloride (source: ndc)
Application Number ANDA078466 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
  • 20 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (68180-758-01)
  • 500 CAPSULE in 1 BOTTLE (68180-758-02)
source: ndc

Packages (2)

68180-758-01 100 CAPSULE in 1 BOTTLE (68180-758-01) 68180-758-02 500 CAPSULE in 1 BOTTLE (68180-758-02)

Ingredients (2)

amlodipine besylate (10 mg/1) benazepril hydrochloride (20 mg/1)

Linked Drug Pages (1)

Amlodipine Besylate and Benazepril Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "53566d4f-ff40-4815-b922-3416cde56fb1", "openfda": {"upc": ["0368180459019"], "unii": ["864V2Q084H", "N1SN99T69T"], "rxcui": ["898342", "898346", "898350", "898353", "898356", "898359"], "spl_set_id": ["968c611b-43a7-40f0-9ed3-aa67ee88364b"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (68180-758-01)", "package_ndc": "68180-758-01", "marketing_start_date": "20100205"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (68180-758-02)", "package_ndc": "68180-758-02", "marketing_start_date": "20100205"}], "brand_name": "Amlodipine Besylate and Benazepril Hydrochloride", "product_id": "68180-758_53566d4f-ff40-4815-b922-3416cde56fb1", "dosage_form": "CAPSULE", "pharm_class": ["Angiotensin Converting Enzyme Inhibitor [EPC]", "Angiotensin-converting Enzyme Inhibitors [MoA]", "Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A Inhibitors [MoA]", "Decreased Blood Pressure [PE]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "68180-758", "generic_name": "Amlodipine Besylate and Benazepril Hydrochloride", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amlodipine Besylate and Benazepril Hydrochloride", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "10 mg/1"}, {"name": "BENAZEPRIL HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA078466", "marketing_category": "ANDA", "marketing_start_date": "20100205", "listing_expiration_date": "20261231"}