carvedilol

Generic: carvedilol

Labeler: unichem pharmaceuticals (usa), inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name carvedilol
Generic Name carvedilol
Labeler unichem pharmaceuticals (usa), inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

carvedilol 12.5 mg/1

Manufacturer
UNICHEM PHARMACEUTICALS (USA), INC.

Identifiers & Regulatory

Product NDC 76385-112
Product ID 76385-112_4aa597d4-9141-4bef-a4d5-03b111958338
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078384
Listing Expiration 2027-12-31
Marketing Start 2016-10-01

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 76385112
Hyphenated Format 76385-112

Supplemental Identifiers

RxCUI
200031 200032 200033 686924
UNII
0K47UL67F2
NUI
N0000000099 N0000009923 N0000009924 N0000175553 N0000175556

Packaging Origin

Original Packager
true

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 ANDA078384 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76385-112-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76385-112-50)
source: ndc

Packages (2)

76385-112-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76385-112-01) 76385-112-50 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76385-112-50)

Ingredients (1)

carvedilol (12.5 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": "4aa597d4-9141-4bef-a4d5-03b111958338", "openfda": {"nui": ["N0000000099", "N0000009923", "N0000009924", "N0000175553", "N0000175556"], "unii": ["0K47UL67F2"], "rxcui": ["200031", "200032", "200033", "686924"], "spl_set_id": ["33dfcf29-19d6-46ba-b8ed-d59d2226ad07"], "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": ["UNICHEM PHARMACEUTICALS (USA), INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76385-112-01)", "package_ndc": "76385-112-01", "marketing_start_date": "20161001"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76385-112-50)", "package_ndc": "76385-112-50", "marketing_start_date": "20161001"}], "brand_name": "Carvedilol", "product_id": "76385-112_4aa597d4-9141-4bef-a4d5-03b111958338", "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": "76385-112", "generic_name": "Carvedilol", "labeler_name": "UNICHEM PHARMACEUTICALS (USA), INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carvedilol", "active_ingredients": [{"name": "CARVEDILOL", "strength": "12.5 mg/1"}], "application_number": "ANDA078384", "marketing_category": "ANDA", "marketing_start_date": "20161001", "listing_expiration_date": "20271231"}