carvedilol

Generic: carvedilol

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

Drug Facts

Product Profile

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

carvedilol 25 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8231
Product ID 68788-8231_e591fdd8-b68b-460b-ae74-8c23b8f65d91
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078165
Listing Expiration 2026-12-31
Marketing Start 2022-08-08

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 687888231
Hyphenated Format 68788-8231

Supplemental Identifiers

RxCUI
200033
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 ANDA078165 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (68788-8231-1)
  • 30 TABLET, FILM COATED in 1 BOTTLE (68788-8231-3)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68788-8231-9)
source: ndc

Packages (3)

68788-8231-1 100 TABLET, FILM COATED in 1 BOTTLE (68788-8231-1) 68788-8231-3 30 TABLET, FILM COATED in 1 BOTTLE (68788-8231-3) 68788-8231-9 90 TABLET, FILM COATED in 1 BOTTLE (68788-8231-9)

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": "e591fdd8-b68b-460b-ae74-8c23b8f65d91", "openfda": {"nui": ["N0000000099", "N0000009923", "N0000009924", "N0000175553", "N0000175556"], "unii": ["0K47UL67F2"], "rxcui": ["200033"], "spl_set_id": ["8d3937b4-e0dd-4165-9825-bbf5020d79f9"], "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": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (68788-8231-1)", "package_ndc": "68788-8231-1", "marketing_start_date": "20220808"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68788-8231-3)", "package_ndc": "68788-8231-3", "marketing_start_date": "20220808"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68788-8231-9)", "package_ndc": "68788-8231-9", "marketing_start_date": "20240321"}], "brand_name": "CARVEDILOL", "product_id": "68788-8231_e591fdd8-b68b-460b-ae74-8c23b8f65d91", "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": "68788-8231", "generic_name": "CARVEDILOL", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CARVEDILOL", "active_ingredients": [{"name": "CARVEDILOL", "strength": "25 mg/1"}], "application_number": "ANDA078165", "marketing_category": "ANDA", "marketing_start_date": "20220808", "listing_expiration_date": "20261231"}