methadone hydrochloride (51991-002)

Drug Facts

Product Profile

Brand Name methadone hydrochloride

Generic Name methadone hydrochloride

Labeler breckenridge pharmaceutical inc

Dosage Form INJECTION, SOLUTION

Routes

INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS

Active Ingredients

methadone hydrochloride 10 mg/mL

Manufacturer

Breckenridge Pharmaceutical Inc

Identifiers & Regulatory

Product NDC 51991-002

Product ID 51991-002_eec50ad6-d9ae-42df-ae5e-9cd75199148e

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA218252

DEA Schedule cii

Listing Expiration 2026-12-31

Marketing Start 2024-12-30

Pharmacologic Class

Classes

full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51991002

Hyphenated Format 51991-002

Supplemental Identifiers

RxCUI

864714

UNII

229809935B

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 methadone hydrochloride (source: ndc)

Generic Name methadone hydrochloride (source: ndc)

Application Number ANDA218252 (source: ndc)

Routes

INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS

source: ndc

Resolved Composition

Strengths

10 mg/mL

source: ndc

Packaging

1 VIAL, GLASS in 1 CARTON (51991-002-98) / 20 mL in 1 VIAL, GLASS

source: ndc

Packages (1)

51991-002-98 1 VIAL, GLASS in 1 CARTON (51991-002-98) / 20 mL in 1 VIAL, GLASS

Ingredients (1)

methadone hydrochloride (10 mg/mL)

Linked Drug Pages (1)

Methadone Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["INTRAMUSCULAR", "INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "eec50ad6-d9ae-42df-ae5e-9cd75199148e", "openfda": {"unii": ["229809935B"], "rxcui": ["864714"], "spl_set_id": ["13541167-95f4-4cb9-9d7d-3c1aced5c5f6"], "manufacturer_name": ["Breckenridge Pharmaceutical Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (51991-002-98)  / 20 mL in 1 VIAL, GLASS", "package_ndc": "51991-002-98", "marketing_start_date": "20241230"}], "brand_name": "Methadone Hydrochloride", "product_id": "51991-002_eec50ad6-d9ae-42df-ae5e-9cd75199148e", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "51991-002", "dea_schedule": "CII", "generic_name": "Methadone Hydrochloride", "labeler_name": "Breckenridge Pharmaceutical Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methadone Hydrochloride", "active_ingredients": [{"name": "METHADONE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA218252", "marketing_category": "ANDA", "marketing_start_date": "20241230", "listing_expiration_date": "20261231"}