carvedilol

Generic: carvedilol

Labeler: dr. reddy's laboratories limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name carvedilol
Generic Name carvedilol
Labeler dr. reddy's laboratories limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

carvedilol 6.25 mg/1

Manufacturer
Dr. Reddy's Laboratories Limited

Identifiers & Regulatory

Product NDC 55111-253
Product ID 55111-253_31305b0b-ee75-85e9-081c-73d15c0a7b83
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076649
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 55111253
Hyphenated Format 55111-253

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 ANDA076649 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6.25 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (55111-253-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (55111-253-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (55111-253-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE (55111-253-30)
  • 10 BLISTER PACK in 1 CARTON (55111-253-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-253-79)
source: ndc

Packages (5)

55111-253-01 100 TABLET, FILM COATED in 1 BOTTLE (55111-253-01) 55111-253-05 500 TABLET, FILM COATED in 1 BOTTLE (55111-253-05) 55111-253-10 1000 TABLET, FILM COATED in 1 BOTTLE (55111-253-10) 55111-253-30 30 TABLET, FILM COATED in 1 BOTTLE (55111-253-30) 55111-253-78 10 BLISTER PACK in 1 CARTON (55111-253-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-253-79)

Ingredients (1)

carvedilol (6.25 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": "31305b0b-ee75-85e9-081c-73d15c0a7b83", "openfda": {"nui": ["N0000000099", "N0000009923", "N0000009924", "N0000175553", "N0000175556"], "unii": ["0K47UL67F2"], "rxcui": ["200031", "200032", "200033", "686924"], "spl_set_id": ["1e453c21-a8a8-dc54-5591-74c972d41727"], "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": ["Dr. Reddy's Laboratories Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (55111-253-01)", "package_ndc": "55111-253-01", "marketing_start_date": "20070905"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (55111-253-05)", "package_ndc": "55111-253-05", "marketing_start_date": "20070905"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (55111-253-10)", "package_ndc": "55111-253-10", "marketing_start_date": "20070905"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (55111-253-30)", "package_ndc": "55111-253-30", "marketing_start_date": "20070905"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (55111-253-78)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-253-79)", "package_ndc": "55111-253-78", "marketing_start_date": "20070905"}], "brand_name": "Carvedilol", "product_id": "55111-253_31305b0b-ee75-85e9-081c-73d15c0a7b83", "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": "55111-253", "generic_name": "Carvedilol", "labeler_name": "Dr. Reddy's Laboratories Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carvedilol", "active_ingredients": [{"name": "CARVEDILOL", "strength": "6.25 mg/1"}], "application_number": "ANDA076649", "marketing_category": "ANDA", "marketing_start_date": "20070905", "listing_expiration_date": "20261231"}