NDC 0904-6530

Methadone Hydrochloride

Methadone Hydrochloride

Methadone Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Major Pharmaceuticals. The primary component is Methadone Hydrochloride.

Product ID0904-6530_9f353aee-c752-4c68-a915-60d987c85c57
NDC0904-6530
Product TypeHuman Prescription Drug
Proprietary NameMethadone Hydrochloride
Generic NameMethadone Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2012-01-16
Marketing CategoryANDA / ANDA
Application NumberANDA090635
Labeler NameMajor Pharmaceuticals
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 0904-6530-61

100 BLISTER PACK in 1 CARTON (0904-6530-61) > 1 TABLET in 1 BLISTER PACK
Marketing Start Date2012-01-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-6530-60 [00904653060]

Methadone Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090635
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-01-16
Marketing End Date2017-12-31

NDC 0904-6530-61 [00904653061]

Methadone Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090635
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-01-16

Drug Details

Active Ingredients

IngredientStrength
METHADONE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:f7805bcf-023a-48df-a5c9-23a04d11d621
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 864706

    • Pharmacological Class

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