methadone hydrochloride

Generic: methadone hydrochloride

Labeler: long grove pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methadone hydrochloride
Generic Name methadone hydrochloride
Labeler long grove pharmaceuticals, llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

methadone hydrochloride 200 mg/20mL

Manufacturer
Long Grove Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 81298-7500
Product ID 81298-7500_46a3297c-98d2-48ef-a7a9-9776ed80e0bd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208306
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2025-06-28

Pharmacologic Class

Classes
full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 812987500
Hyphenated Format 81298-7500

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 ANDA208306 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 200 mg/20mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (81298-7500-1) / 20 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

81298-7500-1 1 VIAL, GLASS in 1 CARTON (81298-7500-1) / 20 mL in 1 VIAL, GLASS

Ingredients (1)

methadone hydrochloride (200 mg/20mL)

Linked Drug Pages (1)

Methadone Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "46a3297c-98d2-48ef-a7a9-9776ed80e0bd", "openfda": {"unii": ["229809935B"], "rxcui": ["864714"], "spl_set_id": ["f453f1b9-d46e-4be8-835d-dbeb9d98a149"], "manufacturer_name": ["Long Grove Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (81298-7500-1)  / 20 mL in 1 VIAL, GLASS", "package_ndc": "81298-7500-1", "marketing_start_date": "20250628"}], "brand_name": "Methadone Hydrochloride", "product_id": "81298-7500_46a3297c-98d2-48ef-a7a9-9776ed80e0bd", "dosage_form": "INJECTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "81298-7500", "dea_schedule": "CII", "generic_name": "Methadone Hydrochloride", "labeler_name": "Long Grove Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methadone Hydrochloride", "active_ingredients": [{"name": "METHADONE HYDROCHLORIDE", "strength": "200 mg/20mL"}], "application_number": "ANDA208306", "marketing_category": "ANDA", "marketing_start_date": "20250628", "listing_expiration_date": "20261231"}