Oxycodone Hydrochloride
Oxycodone Hydrochloride Tablets USP CII
Approved
Approval ID
824f98e1-620b-41e5-8453-864bb67b4358
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 2, 2011
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Oxycodone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52959-130
Application NumberANDA091313
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxycodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 2, 2011
FDA Product Classification
INGREDIENTS (6)
Oxycodone HydrochlorideActive
Quantity: 30 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT