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OXYCODONE HYDROCHLORIDE

OXYCODONE HYDROCHLORIDE TABLETS, USP5 mg, 15 mg, and 30 mg CII Rx only

Approved
Approval ID

c3ba0928-0eff-488e-8a29-fffdb1afdb60

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 26, 2010

Manufacturers
FDA

STAT RX USA LLC

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

NDC Product Code16590-659
Application NumberANDA077712
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 26, 2010
Generic NameOXYCODONE HYDROCHLORIDE

INGREDIENTS (9)

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
OXYCODONE HYDROCHLORIDEActive
Quantity: 15 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT

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OXYCODONE HYDROCHLORIDE - FDA Drug Approval Details