Oxycodone and Acetaminophen
OXYCODONE AND ACETAMINOPHEN TABLETS, USP 5 mg*/325 mg, 7.5 mg*/325 mg, 10 mg*/325 mg CII
Approved
Approval ID
5999f3c3-3225-4d24-82cd-0b8d7a309587
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 2, 2024
Manufacturers
FDA
Rhodes Pharmaceuticals L.P.
DUNS: 831928986
Products 3
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 Code42858-103
Application NumberANDA201278
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxycodone and Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 2, 2024
FDA Product Classification
INGREDIENTS (9)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
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
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
Oxycodone and Acetaminophen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42858-104
Application NumberANDA201278
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxycodone and Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 2, 2024
FDA Product Classification
INGREDIENTS (9)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
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
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
Oxycodone and Acetaminophen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42858-102
Application NumberANDA201278
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxycodone and Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 2, 2024
FDA Product Classification
INGREDIENTS (9)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
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
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT