carvedilol

Generic: carvedilol

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

Drug Facts

Product Profile

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

carvedilol 12.5 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4389
Product ID 70518-4389_40320a33-73b7-c689-e063-6394a90aa708
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077614
Listing Expiration 2026-12-31
Marketing Start 2025-07-08

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 705184389
Hyphenated Format 70518-4389

Supplemental Identifiers

RxCUI
200032
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
  • 12.5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4389-0)
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4389-1)
source: ndc

Packages (2)

70518-4389-0 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4389-0) 70518-4389-1 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4389-1)

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": "40320a33-73b7-c689-e063-6394a90aa708", "openfda": {"nui": ["N0000000099", "N0000009923", "N0000009924", "N0000175553", "N0000175556"], "unii": ["0K47UL67F2"], "rxcui": ["200032"], "spl_set_id": ["d7d6bfff-fbb6-4a1f-aa13-babbb9a1e878"], "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": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4389-0)", "package_ndc": "70518-4389-0", "marketing_start_date": "20250708"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4389-1)", "package_ndc": "70518-4389-1", "marketing_start_date": "20250819"}], "brand_name": "Carvedilol", "product_id": "70518-4389_40320a33-73b7-c689-e063-6394a90aa708", "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": "70518-4389", "generic_name": "Carvedilol", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carvedilol", "active_ingredients": [{"name": "CARVEDILOL", "strength": "12.5 mg/1"}], "application_number": "ANDA077614", "marketing_category": "ANDA", "marketing_start_date": "20250708", "listing_expiration_date": "20261231"}