PERCOCET
Revised: AUGUST 2020
Approved
Approval ID
4dd36cf5-8f73-404a-8b1d-3bd53bd90c25
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 12, 2022
Manufacturers
FDA
Endo Pharmaceuticals Inc.
DUNS: 178074951
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
oxycodone hydrochloride and acetaminophen
PRODUCT DETAILS
NDC Product Code63481-628
Application NumberANDA040330
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJuly 12, 2022
Generic Nameoxycodone hydrochloride and acetaminophen
INGREDIENTS (10)
OXYCODONE HYDROCHLORIDEActive
Quantity: 7.5 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
oxycodone hydrochloride and acetaminophen
PRODUCT DETAILS
NDC Product Code63481-623
Application NumberANDA040330
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJuly 12, 2022
Generic Nameoxycodone hydrochloride and acetaminophen
INGREDIENTS (10)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
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
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
oxycodone hydrochloride and acetaminophen
PRODUCT DETAILS
NDC Product Code63481-629
Application NumberANDA040330
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJuly 12, 2022
Generic Nameoxycodone hydrochloride and acetaminophen
INGREDIENTS (10)
OXYCODONE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
oxycodone hydrochloride and acetaminophen
PRODUCT DETAILS
NDC Product Code63481-627
Application NumberANDA040330
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJuly 12, 2022
Generic Nameoxycodone hydrochloride and acetaminophen
INGREDIENTS (10)
OXYCODONE HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT