carvedilol

Generic: carvedilol

Labeler: advagen pharma ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name carvedilol
Generic Name carvedilol
Labeler advagen pharma ltd
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

carvedilol 3.125 mg/1

Manufacturer
Advagen Pharma Ltd

Identifiers & Regulatory

Product NDC 72888-034
Product ID 72888-034_4b7db91d-a37b-1e8e-e063-6394a90ab2cf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078165
Listing Expiration 2027-12-31
Marketing Start 2021-07-29

Pharmacologic Class

Established (EPC)
alpha-adrenergic blocker [epc] beta-adrenergic blocker [epc]
Mechanism of Action
adrenergic alpha-antagonists [moa] adrenergic beta1-antagonists [moa] adrenergic beta2-antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72888034
Hyphenated Format 72888-034

Supplemental Identifiers

RxCUI
200031 200032 200033 686924
UPC
0372888035000 0372888034003 0372888037004 0372888037011 0372888034300 0372888035017 0372888034058 0372888035055 0372888036007 0372888035307 0372888037059 0372888036052
UNII
0K47UL67F2
NUI
N0000000099 N0000009923 N0000009924 N0000175553 N0000175556

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 carvedilol (source: ndc)
Generic Name carvedilol (source: ndc)
Application Number ANDA078165 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3.125 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE (72888-034-00)
  • 100 TABLET, FILM COATED in 1 BOTTLE (72888-034-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (72888-034-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (72888-034-30)
source: ndc

Packages (4)

72888-034-00 1000 TABLET, FILM COATED in 1 BOTTLE (72888-034-00) 72888-034-01 100 TABLET, FILM COATED in 1 BOTTLE (72888-034-01) 72888-034-05 500 TABLET, FILM COATED in 1 BOTTLE (72888-034-05) 72888-034-30 30 TABLET, FILM COATED in 1 BOTTLE (72888-034-30)

Ingredients (1)

carvedilol (3.125 mg/1)

Linked Drug Pages (1)

CARVEDILOL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4b7db91d-a37b-1e8e-e063-6394a90ab2cf", "openfda": {"nui": ["N0000000099", "N0000009923", "N0000009924", "N0000175553", "N0000175556"], "upc": ["0372888035000", "0372888034003", "0372888037004", "0372888037011", "0372888034300", "0372888035017", "0372888034058", "0372888035055", "0372888036007", "0372888035307", "0372888037059", "0372888036052"], "unii": ["0K47UL67F2"], "rxcui": ["200031", "200032", "200033", "686924"], "spl_set_id": ["7a7d3ca1-05b0-4c7e-aefa-492cc441585d"], "pharm_class_epc": ["alpha-Adrenergic Blocker [EPC]", "beta-Adrenergic Blocker [EPC]"], "pharm_class_moa": ["Adrenergic alpha-Antagonists [MoA]", "Adrenergic beta1-Antagonists [MoA]", "Adrenergic beta2-Antagonists [MoA]"], "manufacturer_name": ["Advagen Pharma Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (72888-034-00)", "package_ndc": "72888-034-00", "marketing_start_date": "20210729"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (72888-034-01)", "package_ndc": "72888-034-01", "marketing_start_date": "20210729"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (72888-034-05)", "package_ndc": "72888-034-05", "marketing_start_date": "20210729"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72888-034-30)", "package_ndc": "72888-034-30", "marketing_start_date": "20210729"}], "brand_name": "CARVEDILOL", "product_id": "72888-034_4b7db91d-a37b-1e8e-e063-6394a90ab2cf", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Adrenergic alpha-Antagonists [MoA]", "Adrenergic beta1-Antagonists [MoA]", "Adrenergic beta2-Antagonists [MoA]", "alpha-Adrenergic Blocker [EPC]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "72888-034", "generic_name": "CARVEDILOL", "labeler_name": "Advagen Pharma Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CARVEDILOL", "active_ingredients": [{"name": "CARVEDILOL", "strength": "3.125 mg/1"}], "application_number": "ANDA078165", "marketing_category": "ANDA", "marketing_start_date": "20210729", "listing_expiration_date": "20271231"}