carvedilol

Generic: carvedilol

Labeler: northwind health company, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name carvedilol
Generic Name carvedilol
Labeler northwind health company, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

carvedilol 25 mg/1

Manufacturer
Northwind Health Company, LLC

Identifiers & Regulatory

Product NDC 51655-397
Product ID 51655-397_49dc05cf-35ca-a384-e063-6294a90a07e1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077614
Listing Expiration 2027-12-31
Marketing Start 2020-07-08

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 51655397
Hyphenated Format 51655-397

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 ANDA077614 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-397-25)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-397-26)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-397-52)
  • 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-397-83)
source: ndc

Packages (4)

51655-397-25 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-397-25) 51655-397-26 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-397-26) 51655-397-52 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-397-52) 51655-397-83 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-397-83)

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": "49dc05cf-35ca-a384-e063-6294a90a07e1", "openfda": {"nui": ["N0000000099", "N0000009923", "N0000009924", "N0000175553", "N0000175556"], "unii": ["0K47UL67F2"], "rxcui": ["200033"], "spl_set_id": ["b0887c72-bc6a-010d-e053-2995a90aab8d"], "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": ["Northwind Health Company, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-397-25)", "package_ndc": "51655-397-25", "marketing_start_date": "20220209"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-397-26)", "package_ndc": "51655-397-26", "marketing_start_date": "20200708"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-397-52)", "package_ndc": "51655-397-52", "marketing_start_date": "20220209"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-397-83)", "package_ndc": "51655-397-83", "marketing_start_date": "20230310"}], "brand_name": "Carvedilol", "product_id": "51655-397_49dc05cf-35ca-a384-e063-6294a90a07e1", "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": "51655-397", "generic_name": "Carvedilol", "labeler_name": "Northwind Health Company, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carvedilol", "active_ingredients": [{"name": "CARVEDILOL", "strength": "25 mg/1"}], "application_number": "ANDA077614", "marketing_category": "ANDA", "marketing_start_date": "20200708", "listing_expiration_date": "20271231"}