OXYCODONE AND ACETAMINOPHEN
oxy+tylenol 5/325mg
Approved
Approval ID
f45ea376-a6e8-52a8-e053-2995a90a7dca
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 9, 2023
Manufacturers
FDA
Redpharm Drug, Inc
DUNS: 828374897
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
oxycodone and acetaminophen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67296-1855
Application NumberANDA207510
Product Classification
M
Marketing Category
C73584
G
Generic Name
oxycodone and acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateMarch 9, 2023
FDA Product Classification
INGREDIENTS (10)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
OXYCODONE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB