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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63481-628
Application NumberANDA040330
Product Classification
M
Marketing Category
C73584
G
Generic Name
oxycodone hydrochloride and acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateJuly 12, 2022
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63481-623
Application NumberANDA040330
Product Classification
M
Marketing Category
C73584
G
Generic Name
oxycodone hydrochloride and acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateJuly 12, 2022
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63481-629
Application NumberANDA040330
Product Classification
M
Marketing Category
C73584
G
Generic Name
oxycodone hydrochloride and acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateJuly 12, 2022
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63481-627
Application NumberANDA040330
Product Classification
M
Marketing Category
C73584
G
Generic Name
oxycodone hydrochloride and acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateJuly 12, 2022
FDA Product Classification
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