amlodipine besylate 10 mg

Generic: amlodipine besylate

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

Drug Facts

Product Profile

Brand Name amlodipine besylate 10 mg
Generic Name amlodipine besylate
Labeler nucare pharmaceuticals,inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amlodipine besylate 10 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-3453
Product ID 68071-3453_1492b8f5-b3d0-9497-e063-6394a90a008e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078414
Listing Expiration 2026-12-31
Marketing Start 2021-10-01

Pharmacologic Class

Classes
calcium channel antagonists [moa] calcium channel blocker [epc] cytochrome p450 3a inhibitors [moa] dihydropyridine calcium channel blocker [epc] dihydropyridines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680713453
Hyphenated Format 68071-3453

Supplemental Identifiers

RxCUI
308135
UPC
0368071345322
UNII
864V2Q084H

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 10 mg (source: ndc)
Generic Name amlodipine besylate (source: ndc)
Application Number ANDA078414 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 120 TABLET in 1 BOTTLE (68071-3453-2)
  • 30 TABLET in 1 BOTTLE (68071-3453-3)
  • 90 TABLET in 1 BOTTLE (68071-3453-9)
source: ndc

Packages (3)

68071-3453-2 120 TABLET in 1 BOTTLE (68071-3453-2) 68071-3453-3 30 TABLET in 1 BOTTLE (68071-3453-3) 68071-3453-9 90 TABLET in 1 BOTTLE (68071-3453-9)

Ingredients (1)

amlodipine besylate (10 mg/1)

Linked Drug Pages (1)

AMLODIPINE BESYLATE 10 mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1492b8f5-b3d0-9497-e063-6394a90a008e", "openfda": {"upc": ["0368071345322"], "unii": ["864V2Q084H"], "rxcui": ["308135"], "spl_set_id": ["ffe96aa1-db66-33e4-e053-6394a90a7e4e"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET in 1 BOTTLE (68071-3453-2)", "package_ndc": "68071-3453-2", "marketing_start_date": "20230707"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68071-3453-3)", "package_ndc": "68071-3453-3", "marketing_start_date": "20230707"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68071-3453-9)", "package_ndc": "68071-3453-9", "marketing_start_date": "20230707"}], "brand_name": "AMLODIPINE BESYLATE 10 mg", "product_id": "68071-3453_1492b8f5-b3d0-9497-e063-6394a90a008e", "dosage_form": "TABLET", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A Inhibitors [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "68071-3453", "generic_name": "AMLODIPINE BESYLATE", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AMLODIPINE BESYLATE", "brand_name_suffix": "10 mg", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "10 mg/1"}], "application_number": "ANDA078414", "marketing_category": "ANDA", "marketing_start_date": "20211001", "listing_expiration_date": "20261231"}