carvedilol

Generic: carvedilol

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name carvedilol
Generic Name carvedilol
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

carvedilol 6.25 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-063
Product ID 71610-063_dc72ac05-4435-4c84-ab22-2514e65b9fde
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078384
Listing Expiration 2026-12-31
Marketing Start 2018-02-01

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 71610063
Hyphenated Format 71610-063

Supplemental Identifiers

RxCUI
200031 200032 200033 686924
UNII
0K47UL67F2
NUI
N0000000099 N0000009923 N0000009924 N0000175553 N0000175556

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 ANDA078384 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6.25 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-063-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-063-53)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-063-60)
  • 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-063-80)
source: ndc

Packages (4)

71610-063-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-063-30) 71610-063-53 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-063-53) 71610-063-60 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-063-60) 71610-063-80 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-063-80)

Ingredients (1)

carvedilol (6.25 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": "dc72ac05-4435-4c84-ab22-2514e65b9fde", "openfda": {"nui": ["N0000000099", "N0000009923", "N0000009924", "N0000175553", "N0000175556"], "unii": ["0K47UL67F2"], "rxcui": ["200031", "200032", "200033", "686924"], "spl_set_id": ["e3f463b5-2743-4a4a-a90a-bf1ee10a5458"], "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": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-063-30)", "package_ndc": "71610-063-30", "marketing_start_date": "20180515"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-063-53)", "package_ndc": "71610-063-53", "marketing_start_date": "20180515"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-063-60)", "package_ndc": "71610-063-60", "marketing_start_date": "20180515"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-063-80)", "package_ndc": "71610-063-80", "marketing_start_date": "20180508"}], "brand_name": "Carvedilol", "product_id": "71610-063_dc72ac05-4435-4c84-ab22-2514e65b9fde", "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": "71610-063", "generic_name": "Carvedilol", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carvedilol", "active_ingredients": [{"name": "CARVEDILOL", "strength": "6.25 mg/1"}], "application_number": "ANDA078384", "marketing_category": "ANDA", "marketing_start_date": "20180201", "listing_expiration_date": "20261231"}