OXYCODONE HYDROCHLORIDE
Approved
Approval ID
25c2a91c-dfc2-4596-8a24-63acf04a2568
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 9, 2010
Manufacturers
FDA
STAT RX LLC USA
DUNS: 786036330
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 Code16590-835
Application NumberANDA078206
Product Classification
M
Marketing Category
C73584
G
Generic Name
OXYCODONE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJuly 9, 2010
FDA Product Classification
INGREDIENTS (4)
OXYCODONE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT