Methamphetamine Hydrochloride
Methamphetamine Hydrochloride Tablets, USP
Approved
Approval ID
f31f580f-1f08-4a0f-b078-0b9e3308f712
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 5, 2023
Manufacturers
FDA
Mayne Pharma Commercial LLC
DUNS: 867220261
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
METHAMPHETAMINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68308-115
Application NumberANDA091189
Product Classification
M
Marketing Category
C73584
G
Generic Name
METHAMPHETAMINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJuly 5, 2023
FDA Product Classification
INGREDIENTS (5)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
METHAMPHETAMINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 997F43Z9CV
Classification: ACTIB