Oxycodone and Aspirin
Approved
Approval ID
946b4df5-f1dc-42a7-acb9-1d2543c9bb44
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 29, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
oxycodone and aspirin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-2094
Application NumberANDA040255
Product Classification
M
Marketing Category
C73584
G
Generic Name
oxycodone and aspirin
Product Specifications
Route of AdministrationORAL
Effective DateAugust 29, 2011
FDA Product Classification
INGREDIENTS (6)
OXYCODONE HYDROCHLORIDEActive
Quantity: 4.5 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
ASPIRINActive
Quantity: 325 mg in 1 1
Code: R16CO5Y76E
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
OXYCODONE TEREPHTHALATEActive
Quantity: 0.38 mg in 1 1
Code: M04XWV43UF
Classification: ACTIB