carvedilol phosphate (0115-1248)

Drug Facts

Product Profile

Brand Name carvedilol phosphate

Generic Name carvedilol phosphate

Labeler amneal pharmaceuticals of new york llc

Dosage Form CAPSULE, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

carvedilol phosphate 10 mg/1

Manufacturer

Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 0115-1248

Product ID 0115-1248_ad7423a5-e5c2-4a50-a338-c25370dba2a6

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA204717

Listing Expiration 2026-12-31

Marketing Start 2024-01-01

Pharmacologic Class

Classes

adrenergic alpha-antagonists [moa] adrenergic beta1-antagonists [moa] adrenergic beta2-antagonists [moa] alpha-adrenergic blocker [epc] beta-adrenergic blocker [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01151248

Hyphenated Format 0115-1248

Supplemental Identifiers

RxCUI

860510 860516 860522 860532

UPC

0301151250086 0301151248083 0301151249080 0301151251083

UNII

EQT531S367

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 phosphate (source: ndc)

Generic Name carvedilol phosphate (source: ndc)

Application Number ANDA204717 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/1

source: ndc

Packaging

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1248-01)
1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1248-03)
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1248-08)
90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1248-10)

source: ndc

Packages (4)

0115-1248-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1248-01) 0115-1248-03 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1248-03) 0115-1248-08 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1248-08) 0115-1248-10 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1248-10)

Ingredients (1)

carvedilol phosphate (10 mg/1)

Linked Drug Pages (1)

Carvedilol Phosphate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "ad7423a5-e5c2-4a50-a338-c25370dba2a6", "openfda": {"upc": ["0301151250086", "0301151248083", "0301151249080", "0301151251083"], "unii": ["EQT531S367"], "rxcui": ["860510", "860516", "860522", "860532"], "spl_set_id": ["fa6b4014-e9d7-4074-95fc-4b48d91da83b"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1248-01)", "package_ndc": "0115-1248-01", "marketing_start_date": "20240101"}, {"sample": false, "description": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1248-03)", "package_ndc": "0115-1248-03", "marketing_start_date": "20240101"}, {"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1248-08)", "package_ndc": "0115-1248-08", "marketing_start_date": "20240101"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1248-10)", "package_ndc": "0115-1248-10", "marketing_start_date": "20240101"}], "brand_name": "Carvedilol Phosphate", "product_id": "0115-1248_ad7423a5-e5c2-4a50-a338-c25370dba2a6", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Adrenergic alpha-Antagonists [MoA]", "Adrenergic beta1-Antagonists [MoA]", "Adrenergic beta2-Antagonists [MoA]", "alpha-Adrenergic Blocker [EPC]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "0115-1248", "generic_name": "CARVEDILOL PHOSPHATE", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carvedilol Phosphate", "active_ingredients": [{"name": "CARVEDILOL PHOSPHATE", "strength": "10 mg/1"}], "application_number": "ANDA204717", "marketing_category": "ANDA", "marketing_start_date": "20240101", "listing_expiration_date": "20261231"}