methadone hydrochloride

Generic: methadone hydrochloride

Labeler: atlantic biologicals corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methadone hydrochloride
Generic Name methadone hydrochloride
Labeler atlantic biologicals corp.
Dosage Form CONCENTRATE
Routes
ORAL
Active Ingredients

methadone hydrochloride 10 mg/mL

Manufacturer
ATLANTIC BIOLOGICALS CORP.

Identifiers & Regulatory

Product NDC 17856-0392
Product ID 17856-0392_36b0bbb0-eb9e-7547-e063-6394a90a25f4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040180
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2019-05-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 178560392
Hyphenated Format 17856-0392

Supplemental Identifiers

RxCUI
991147
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 ANDA040180 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0392-1) / .5 mL in 1 SYRINGE
  • 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0392-3) / 2.5 mL in 1 CUP, UNIT-DOSE (17856-0392-4)
  • 1 SYRINGE in 1 BAG (17856-0392-6) / .5 mL in 1 SYRINGE
  • 5 BOX, UNIT-DOSE in 1 SYRINGE (17856-0392-7) / 60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0392-2) / 1 mL in 1 SYRINGE (17856-0392-5)
  • 1 SYRINGE in 1 BAG (17856-0392-8) / 1 mL in 1 SYRINGE
  • 1 SYRINGE in 1 BAG (17856-0392-9) / 2.5 mL in 1 SYRINGE
source: ndc

Packages (6)

17856-0392-1 60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0392-1) / .5 mL in 1 SYRINGE 17856-0392-3 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0392-3) / 2.5 mL in 1 CUP, UNIT-DOSE (17856-0392-4) 17856-0392-6 1 SYRINGE in 1 BAG (17856-0392-6) / .5 mL in 1 SYRINGE 17856-0392-7 5 BOX, UNIT-DOSE in 1 SYRINGE (17856-0392-7) / 60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0392-2) / 1 mL in 1 SYRINGE (17856-0392-5) 17856-0392-8 1 SYRINGE in 1 BAG (17856-0392-8) / 1 mL in 1 SYRINGE 17856-0392-9 1 SYRINGE in 1 BAG (17856-0392-9) / 2.5 mL in 1 SYRINGE

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": ["ORAL"], "spl_id": "36b0bbb0-eb9e-7547-e063-6394a90a25f4", "openfda": {"unii": ["229809935B"], "rxcui": ["991147"], "spl_set_id": ["d7b30c78-c531-4dc5-9552-d68daa3210d1"], "manufacturer_name": ["ATLANTIC BIOLOGICALS CORP."]}, "finished": true, "packaging": [{"sample": false, "description": "60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0392-1)  / .5 mL in 1 SYRINGE", "package_ndc": "17856-0392-1", "marketing_start_date": "20240520"}, {"sample": false, "description": "72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0392-3)  / 2.5 mL in 1 CUP, UNIT-DOSE (17856-0392-4)", "package_ndc": "17856-0392-3", "marketing_start_date": "20240520"}, {"sample": false, "description": "1 SYRINGE in 1 BAG (17856-0392-6)  / .5 mL in 1 SYRINGE", "package_ndc": "17856-0392-6", "marketing_start_date": "20250530"}, {"sample": false, "description": "5 BOX, UNIT-DOSE in 1 SYRINGE (17856-0392-7)  / 60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0392-2)  / 1 mL in 1 SYRINGE (17856-0392-5)", "package_ndc": "17856-0392-7", "marketing_start_date": "20240520"}, {"sample": false, "description": "1 SYRINGE in 1 BAG (17856-0392-8)  / 1 mL in 1 SYRINGE", "package_ndc": "17856-0392-8", "marketing_start_date": "20250530"}, {"sample": false, "description": "1 SYRINGE in 1 BAG (17856-0392-9)  / 2.5 mL in 1 SYRINGE", "package_ndc": "17856-0392-9", "marketing_start_date": "20250530"}], "brand_name": "Methadone Hydrochloride", "product_id": "17856-0392_36b0bbb0-eb9e-7547-e063-6394a90a25f4", "dosage_form": "CONCENTRATE", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "17856-0392", "dea_schedule": "CII", "generic_name": "Methadone Hydrochloride", "labeler_name": "ATLANTIC BIOLOGICALS CORP.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methadone Hydrochloride", "active_ingredients": [{"name": "METHADONE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA040180", "marketing_category": "ANDA", "marketing_start_date": "20190514", "listing_expiration_date": "20261231"}