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 3.125 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-132
Product ID 71610-132_64a15efb-fbe4-409a-93e4-dc27c54ac748
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078332
Listing Expiration 2026-12-31
Marketing Start 2007-09-05

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 71610132
Hyphenated Format 71610-132

Supplemental Identifiers

RxCUI
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 ANDA078332 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3.125 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (71610-132-53)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71610-132-60)
  • 180 TABLET, FILM COATED in 1 BOTTLE (71610-132-80)
source: ndc

Packages (3)

71610-132-53 60 TABLET, FILM COATED in 1 BOTTLE (71610-132-53) 71610-132-60 90 TABLET, FILM COATED in 1 BOTTLE (71610-132-60) 71610-132-80 180 TABLET, FILM COATED in 1 BOTTLE (71610-132-80)

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": "64a15efb-fbe4-409a-93e4-dc27c54ac748", "openfda": {"nui": ["N0000000099", "N0000009923", "N0000009924", "N0000175553", "N0000175556"], "unii": ["0K47UL67F2"], "rxcui": ["686924"], "spl_set_id": ["d0089df4-37c8-41de-810c-14c9dc06f0c3"], "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": "60 TABLET, FILM COATED in 1 BOTTLE (71610-132-53)", "package_ndc": "71610-132-53", "marketing_start_date": "20180830"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71610-132-60)", "package_ndc": "71610-132-60", "marketing_start_date": "20180830"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (71610-132-80)", "package_ndc": "71610-132-80", "marketing_start_date": "20180830"}], "brand_name": "Carvedilol", "product_id": "71610-132_64a15efb-fbe4-409a-93e4-dc27c54ac748", "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": "71610-132", "generic_name": "Carvedilol", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carvedilol", "active_ingredients": [{"name": "CARVEDILOL", "strength": "3.125 mg/1"}], "application_number": "ANDA078332", "marketing_category": "ANDA", "marketing_start_date": "20070905", "listing_expiration_date": "20261231"}