ENDODAN
Approved
Approval ID
23a60947-6058-4bf7-a3ee-ae396e55d939
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 23, 2011
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 and ASPIRIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-947
Application NumberNDA007337
Product Classification
M
Marketing Category
C73605
G
Generic Name
OXYCODONE and ASPIRIN
Product Specifications
Route of AdministrationORAL
Effective DateMay 23, 2011
FDA Product Classification
INGREDIENTS (6)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
OXYCODONE HYDROCHLORIDEActive
Quantity: 4.8355 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
ASPIRINActive
Quantity: 325 mg in 1 1
Code: R16CO5Y76E
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT