carvedilol

Generic: carvedilol

Labeler: nucare pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

carvedilol 3.125 mg/1

Manufacturer
NuCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68071-3138
Product ID 68071-3138_0ec45c14-def9-b2b9-e063-6294a90a3a3a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077614
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 680713138
Hyphenated Format 68071-3138

Supplemental Identifiers

RxCUI
686924
UPC
0368071313888
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 ANDA077614 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3.125 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (68071-3138-3)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68071-3138-6)
  • 180 TABLET, FILM COATED in 1 BOTTLE (68071-3138-8)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68071-3138-9)
source: ndc

Packages (4)

68071-3138-3 30 TABLET, FILM COATED in 1 BOTTLE (68071-3138-3) 68071-3138-6 60 TABLET, FILM COATED in 1 BOTTLE (68071-3138-6) 68071-3138-8 180 TABLET, FILM COATED in 1 BOTTLE (68071-3138-8) 68071-3138-9 90 TABLET, FILM COATED in 1 BOTTLE (68071-3138-9)

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": "0ec45c14-def9-b2b9-e063-6294a90a3a3a", "openfda": {"nui": ["N0000000099", "N0000009923", "N0000009924", "N0000175553", "N0000175556"], "upc": ["0368071313888"], "unii": ["0K47UL67F2"], "rxcui": ["686924"], "spl_set_id": ["49afdf89-0bed-71da-e054-00144ff88e88"], "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": ["NuCare Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68071-3138-3)", "package_ndc": "68071-3138-3", "marketing_start_date": "20170301"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68071-3138-6)", "package_ndc": "68071-3138-6", "marketing_start_date": "20170301"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (68071-3138-8)", "package_ndc": "68071-3138-8", "marketing_start_date": "20170301"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68071-3138-9)", "package_ndc": "68071-3138-9", "marketing_start_date": "20170301"}], "brand_name": "Carvedilol", "product_id": "68071-3138_0ec45c14-def9-b2b9-e063-6294a90a3a3a", "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": "68071-3138", "generic_name": "Carvedilol", "labeler_name": "NuCare Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carvedilol", "active_ingredients": [{"name": "CARVEDILOL", "strength": "3.125 mg/1"}], "application_number": "ANDA077614", "marketing_category": "ANDA", "marketing_start_date": "20070905", "listing_expiration_date": "20261231"}