OXYCODONE HCL
OXYCODONE HCL 15mg
Approved
Approval ID
2c6296ee-779a-419b-e054-00144ff8d46c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 21, 2020
Manufacturers
FDA
DIRECT RX
DUNS: 079254320
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
OXYCODONE HCL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61919-659
Application NumberANDA090659
Product Classification
M
Marketing Category
C73584
G
Generic Name
OXYCODONE HCL
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 21, 2020
FDA Product Classification
INGREDIENTS (9)
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
OXYCODONE HYDROCHLORIDEActive
Quantity: 15 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB