methadone hydrochloride

Generic: methadone hydrochloride

Labeler: precision dose, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methadone hydrochloride
Generic Name methadone hydrochloride
Labeler precision dose, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

methadone hydrochloride 5 mg/5mL

Manufacturer
Precision Dose, Inc.

Identifiers & Regulatory

Product NDC 68094-331
Product ID 68094-331_f323b0eb-5527-4874-aee6-ef6f49e5784b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA087393
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2023-12-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68094331
Hyphenated Format 68094-331

Supplemental Identifiers

RxCUI
864761
UNII
229809935B

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 ANDA087393 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 50 BAG in 1 CASE (68094-331-58) / 1 SYRINGE, PLASTIC in 1 BAG / 1 mL in 1 SYRINGE, PLASTIC (68094-331-01)
source: ndc

Packages (1)

68094-331-58 50 BAG in 1 CASE (68094-331-58) / 1 SYRINGE, PLASTIC in 1 BAG / 1 mL in 1 SYRINGE, PLASTIC (68094-331-01)

Ingredients (1)

methadone hydrochloride (5 mg/5mL)

Linked Drug Pages (1)

Methadone Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f323b0eb-5527-4874-aee6-ef6f49e5784b", "openfda": {"unii": ["229809935B"], "rxcui": ["864761"], "spl_set_id": ["e980d666-d74d-4358-a3b7-c6accb15eba6"], "manufacturer_name": ["Precision Dose, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "50 BAG in 1 CASE (68094-331-58)  / 1 SYRINGE, PLASTIC in 1 BAG / 1 mL in 1 SYRINGE, PLASTIC (68094-331-01)", "package_ndc": "68094-331-58", "marketing_start_date": "20231229"}], "brand_name": "Methadone Hydrochloride", "product_id": "68094-331_f323b0eb-5527-4874-aee6-ef6f49e5784b", "dosage_form": "SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "68094-331", "dea_schedule": "CII", "generic_name": "Methadone Hydrochloride", "labeler_name": "Precision Dose, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methadone Hydrochloride", "active_ingredients": [{"name": "METHADONE HYDROCHLORIDE", "strength": "5 mg/5mL"}], "application_number": "ANDA087393", "marketing_category": "ANDA", "marketing_start_date": "20231229", "listing_expiration_date": "20261231"}