coreg

Generic: carvedilol

Labeler: waylis therapeutics llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name coreg
Generic Name carvedilol
Labeler waylis therapeutics llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

carvedilol 3.125 mg/1

Manufacturer
Waylis Therapeutics LLC

Identifiers & Regulatory

Product NDC 80725-139
Product ID 80725-139_f2798247-00df-4ec2-a6f8-1902f10b5558
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020297
Listing Expiration 2026-12-31
Marketing Start 2023-03-15

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 80725139
Hyphenated Format 80725-139

Supplemental Identifiers

RxCUI
200031 200032 200033 212388 212389 212390 686924 686926
UPC
0380725141203 0380725140206
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 coreg (source: ndc)
Generic Name carvedilol (source: ndc)
Application Number NDA020297 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3.125 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80725-139-20)
source: ndc

Packages (1)

80725-139-20 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80725-139-20)

Ingredients (1)

carvedilol (3.125 mg/1)

Linked Drug Pages (1)

Coreg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f2798247-00df-4ec2-a6f8-1902f10b5558", "openfda": {"nui": ["N0000000099", "N0000009923", "N0000009924", "N0000175553", "N0000175556"], "upc": ["0380725141203", "0380725140206"], "unii": ["0K47UL67F2"], "rxcui": ["200031", "200032", "200033", "212388", "212389", "212390", "686924", "686926"], "spl_set_id": ["07c619c6-4a0c-445e-94fa-664a54f68a39"], "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": ["Waylis Therapeutics LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80725-139-20)", "package_ndc": "80725-139-20", "marketing_start_date": "20230415"}], "brand_name": "Coreg", "product_id": "80725-139_f2798247-00df-4ec2-a6f8-1902f10b5558", "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": "80725-139", "generic_name": "Carvedilol", "labeler_name": "Waylis Therapeutics LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Coreg", "active_ingredients": [{"name": "CARVEDILOL", "strength": "3.125 mg/1"}], "application_number": "NDA020297", "marketing_category": "NDA", "marketing_start_date": "20230315", "listing_expiration_date": "20261231"}