amlodipine besylate

Generic: amlodipine besylate

Labeler: cipla usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amlodipine besylate
Generic Name amlodipine besylate
Labeler cipla usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amlodipine besylate 5 mg/1

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-127
Product ID 69097-127_7cbe66f6-99fb-403f-9c6b-e4ecc7549eaf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077073
Listing Expiration 2026-12-31
Marketing Start 2007-09-26

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 69097127
Hyphenated Format 69097-127

Supplemental Identifiers

RxCUI
197361 308135 308136
UPC
0369097126056 0369097128050 0369097127053
UNII
864V2Q084H

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 (source: ndc)
Generic Name amlodipine besylate (source: ndc)
Application Number ANDA077073 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (69097-127-05)
  • 1000 TABLET in 1 BOTTLE (69097-127-15)
source: ndc

Packages (2)

69097-127-05 90 TABLET in 1 BOTTLE (69097-127-05) 69097-127-15 1000 TABLET in 1 BOTTLE (69097-127-15)

Ingredients (1)

amlodipine besylate (5 mg/1)

Linked Drug Pages (1)

AMLODIPINE BESYLATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7cbe66f6-99fb-403f-9c6b-e4ecc7549eaf", "openfda": {"upc": ["0369097126056", "0369097128050", "0369097127053"], "unii": ["864V2Q084H"], "rxcui": ["197361", "308135", "308136"], "spl_set_id": ["5409b296-3bed-47cd-abba-9fe6f6833af6"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (69097-127-05)", "package_ndc": "69097-127-05", "marketing_start_date": "20070926"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (69097-127-15)", "package_ndc": "69097-127-15", "marketing_start_date": "20070926"}], "brand_name": "AMLODIPINE BESYLATE", "product_id": "69097-127_7cbe66f6-99fb-403f-9c6b-e4ecc7549eaf", "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": "69097-127", "generic_name": "AMLODIPINE BESYLATE", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AMLODIPINE BESYLATE", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "5 mg/1"}], "application_number": "ANDA077073", "marketing_category": "ANDA", "marketing_start_date": "20070926", "listing_expiration_date": "20261231"}