carvedilol

Generic: carvedilol

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name carvedilol
Generic Name carvedilol
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

carvedilol 3.125 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-126
Product ID 43063-126_41376da3-5277-b133-e063-6394a90afa13
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 43063126
Hyphenated Format 43063-126

Supplemental Identifiers

RxCUI
686924
UPC
0343063126936
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, PLASTIC (43063-126-60)
  • 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-126-93)
source: ndc

Packages (2)

43063-126-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-126-60) 43063-126-93 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-126-93)

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": "41376da3-5277-b133-e063-6394a90afa13", "openfda": {"nui": ["N0000000099", "N0000009923", "N0000009924", "N0000175553", "N0000175556"], "upc": ["0343063126936"], "unii": ["0K47UL67F2"], "rxcui": ["686924"], "spl_set_id": ["8640adde-d071-44a4-97d0-fa8a8548debe"], "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": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-126-60)", "package_ndc": "43063-126-60", "marketing_start_date": "20131030"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-126-93)", "package_ndc": "43063-126-93", "marketing_start_date": "20131030"}], "brand_name": "Carvedilol", "product_id": "43063-126_41376da3-5277-b133-e063-6394a90afa13", "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": "43063-126", "generic_name": "Carvedilol", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "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"}