coreg cr

Generic: carvedilol phosphate

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

Drug Facts

Product Profile

Brand Name coreg cr
Generic Name carvedilol phosphate
Labeler waylis therapeutics llc
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

carvedilol phosphate 20 mg/1

Manufacturer
Waylis Therapeutics LLC

Identifiers & Regulatory

Product NDC 80725-385
Product ID 80725-385_d756f678-86ff-4187-9cc1-68dd3a383af8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022012
Listing Expiration 2026-12-31
Marketing Start 2022-11-07

Pharmacologic Class

Classes
adrenergic alpha-antagonists [moa] adrenergic beta1-antagonists [moa] adrenergic beta2-antagonists [moa] alpha-adrenergic blocker [epc] beta-adrenergic blocker [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 80725385
Hyphenated Format 80725-385

Supplemental Identifiers

RxCUI
860510 860512 860516 860518 860522 860524 860532 860534
UPC
0380725387137 0380725388134 0380725385133 0380725383139
UNII
EQT531S367

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 cr (source: ndc)
Generic Name carvedilol phosphate (source: ndc)
Application Number NDA022012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (80725-385-13)
source: ndc

Packages (1)

80725-385-13 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (80725-385-13)

Ingredients (1)

carvedilol phosphate (20 mg/1)

Linked Drug Pages (1)

Coreg CR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d756f678-86ff-4187-9cc1-68dd3a383af8", "openfda": {"upc": ["0380725387137", "0380725388134", "0380725385133", "0380725383139"], "unii": ["EQT531S367"], "rxcui": ["860510", "860512", "860516", "860518", "860522", "860524", "860532", "860534"], "spl_set_id": ["d3625d78-6eb6-41fe-8f6f-664965c104c4"], "manufacturer_name": ["Waylis Therapeutics LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (80725-385-13)", "package_ndc": "80725-385-13", "marketing_start_date": "20221107"}], "brand_name": "Coreg CR", "product_id": "80725-385_d756f678-86ff-4187-9cc1-68dd3a383af8", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Antagonists [MoA]", "Adrenergic beta1-Antagonists [MoA]", "Adrenergic beta2-Antagonists [MoA]", "alpha-Adrenergic Blocker [EPC]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "80725-385", "generic_name": "Carvedilol Phosphate", "labeler_name": "Waylis Therapeutics LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Coreg CR", "active_ingredients": [{"name": "CARVEDILOL PHOSPHATE", "strength": "20 mg/1"}], "application_number": "NDA022012", "marketing_category": "NDA", "marketing_start_date": "20221107", "listing_expiration_date": "20261231"}