NDC 13107-089

Methadone Hydrochloride

Methadone Hydrochloride

Methadone Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Aurolife Pharma, Llc. The primary component is Methadone Hydrochloride.

Product ID13107-089_20888bd6-1d9a-4473-80e9-73ee4cfb5d7f
NDC13107-089
Product TypeHuman Prescription Drug
Proprietary NameMethadone Hydrochloride
Generic NameMethadone Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2015-09-15
Marketing CategoryANDA / ANDA
Application NumberANDA203502
Labeler NameAurolife Pharma, LLC
Substance NameMETHADONE HYDROCHLORIDE
Active Ingredient Strength10 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 13107-089-01

100 TABLET in 1 BOTTLE (13107-089-01)
Marketing Start Date2015-09-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 13107-089-01 [13107008901]

Methadone Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA203502
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-09-15

NDC 13107-089-30 [13107008930]

Methadone Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA203502
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-09-15

NDC 13107-089-99 [13107008999]

Methadone Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA203502
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-09-15

Drug Details

Active Ingredients

IngredientStrength
METHADONE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:6984eb5a-57a3-4686-bc67-91bc3e7a531e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 864718
  • 864706
    • UPC Code
  • 0313107088018
  • 0313107089015

    • Pharmacological Class

    • Full Opioid Agonists [MoA]
    • Opioid Agonist [EPC]

    Medicade Reported Pricing

    13107008901 METHADONE HCL 10 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Methadone Hydrochloride" or generic name "Methadone Hydrochloride"

    NDCBrand NameGeneric Name
    0054-0391Methadone HydrochlorideMethadone Hydrochloride
    0054-0392Methadone HydrochlorideMethadone Hydrochloride
    0054-0709METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    0054-0710METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    0054-3553Methadone HydrochlorideMethadone Hydrochloride
    0054-3555Methadone HydrochlorideMethadone Hydrochloride
    0054-3556Methadone HydrochlorideMethadone Hydrochloride
    0054-4570METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    67877-116Methadone HydrochlorideMethadone Hydrochloride
    68084-738METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    68462-801Methadone HydrochlorideMethadone Hydrochloride
    68462-800Methadone HydrochlorideMethadone Hydrochloride
    0054-4571METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    0054-8553METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    0054-8554METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    70166-284Methadone HydrochlorideMethadone Hydrochloride
    71335-0119METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    71335-0735Methadone HydrochlorideMethadone Hydrochloride
    71335-0493Methadone HydrochlorideMethadone Hydrochloride
    0904-6530Methadone HydrochlorideMethadone Hydrochloride
    13107-088Methadone HydrochlorideMethadone Hydrochloride
    13107-089Methadone HydrochlorideMethadone Hydrochloride
    17856-3553Methadone HydrochlorideMethadone Hydrochloride
    17856-3554Methadone HydrochlorideMethadone Hydrochloride
    17478-380Methadone HydrochlorideMethadone Hydrochloride
    17856-3556Methadone HydrochlorideMethadone Hydrochloride
    17856-3555Methadone HydrochlorideMethadone Hydrochloride
    35356-835METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    35356-834METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    42806-318Methadone HydrochlorideMethadone Hydrochloride
    42806-317Methadone HydrochlorideMethadone Hydrochloride
    52959-386METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    52959-435METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    57664-603Methadone hydrochlorideMethadone hydrochloride
    57664-602Methadone hydrochlorideMethadone hydrochloride
    60687-214Methadone HydrochlorideMethadone Hydrochloride
    61919-670METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    63739-006Methadone HydrochlorideMethadone Hydrochloride
    0406-1510Methadone HydrochlorideMethadone Hydrochloride
    0406-2540METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    0406-5755METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    0406-5771METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE
    66689-695Methadone HydrochlorideMethadone Hydrochloride
    66689-694Methadone HydrochlorideMethadone Hydrochloride
    66689-711Methadone HydrochlorideMethadone Hydrochloride
    66689-712Methadone HydrochlorideMethadone Hydrochloride
    66689-810Methadone HydrochlorideMethadone Hydrochloride
    66689-820Methadone HydrochlorideMethadone Hydrochloride
    66689-898Methadone HydrochlorideMethadone Hydrochloride
    67457-217Methadone HydrochlorideMethadone Hydrochloride
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.