carvedilol

Generic: carvedilol

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name carvedilol
Generic Name carvedilol
Labeler proficient rx lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

carvedilol 25 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-138
Product ID 82804-138_baaecdf7-b67a-47f3-b42a-caf413bb9f4f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076373
Listing Expiration 2026-12-31
Marketing Start 2007-09-06

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 82804138
Hyphenated Format 82804-138

Supplemental Identifiers

RxCUI
200033
UPC
0382804138906
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 ANDA076373 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (82804-138-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (82804-138-90)
source: ndc

Packages (2)

82804-138-60 60 TABLET, FILM COATED in 1 BOTTLE (82804-138-60) 82804-138-90 90 TABLET, FILM COATED in 1 BOTTLE (82804-138-90)

Ingredients (1)

carvedilol (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": "baaecdf7-b67a-47f3-b42a-caf413bb9f4f", "openfda": {"nui": ["N0000000099", "N0000009923", "N0000009924", "N0000175553", "N0000175556"], "upc": ["0382804138906"], "unii": ["0K47UL67F2"], "rxcui": ["200033"], "spl_set_id": ["52785a22-ddca-4f5b-8579-5974df2a9a4e"], "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": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (82804-138-60)", "package_ndc": "82804-138-60", "marketing_start_date": "20251204"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (82804-138-90)", "package_ndc": "82804-138-90", "marketing_start_date": "20240906"}], "brand_name": "Carvedilol", "product_id": "82804-138_baaecdf7-b67a-47f3-b42a-caf413bb9f4f", "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": "82804-138", "generic_name": "Carvedilol", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carvedilol", "active_ingredients": [{"name": "CARVEDILOL", "strength": "25 mg/1"}], "application_number": "ANDA076373", "marketing_category": "ANDA", "marketing_start_date": "20070906", "listing_expiration_date": "20261231"}