carvedilol

Generic: carvedilol

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

carvedilol 25 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7308
Product ID 0904-7308_9eee2f7d-7fe9-4b09-a688-d17e8a9f44ff
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078251
Listing Expiration 2027-12-31
Marketing Start 2024-07-01

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 09047308
Hyphenated Format 0904-7308

Supplemental Identifiers

RxCUI
200031 200032 200033 686924
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 ANDA078251 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-7308-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7308-61 100 BLISTER PACK in 1 CARTON (0904-7308-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK

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": "9eee2f7d-7fe9-4b09-a688-d17e8a9f44ff", "openfda": {"nui": ["N0000000099", "N0000009923", "N0000009924", "N0000175553", "N0000175556"], "unii": ["0K47UL67F2"], "rxcui": ["200031", "200032", "200033", "686924"], "spl_set_id": ["ec6d8d73-9d18-4a9e-ae0c-0ea12059e78e"], "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": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-7308-61)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-7308-61", "marketing_start_date": "20240701"}], "brand_name": "Carvedilol", "product_id": "0904-7308_9eee2f7d-7fe9-4b09-a688-d17e8a9f44ff", "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": "0904-7308", "generic_name": "Carvedilol", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carvedilol", "active_ingredients": [{"name": "CARVEDILOL", "strength": "25 mg/1"}], "application_number": "ANDA078251", "marketing_category": "ANDA", "marketing_start_date": "20240701", "listing_expiration_date": "20271231"}