Oxycodone Hydrochloride
OXYCODONE HYDROCHLORIDE TABLETS, USP 8231-06 15 mg and 30 mg CII
Approved
Approval ID
6fa888fc-a9d5-47f3-b28f-660d169875ae
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 10, 2010
Manufacturers
FDA
Blenheim Pharmacal, Inc.
DUNS: 171434587
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 Code10544-005
Application NumberANDA076636
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxycodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 10, 2010
FDA Product Classification
INGREDIENTS (7)
OXYCODONE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT