ACETAMINOPHEN AND CODEINE PHOSPHATE
ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP(300 mg/30 mg, 300 mg/60 mg) CIII Rx only
Approved
Approval ID
3c153389-4361-4a39-b7da-151ffc566f24
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2009
Manufacturers
FDA
Rebel Distributors Corp.
DUNS: 118802834
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
acetaminophen and codeine phosphate
PRODUCT DETAILS
NDC Product Code21695-243
Application NumberANDA040419
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 1, 2009
Generic Nameacetaminophen and codeine phosphate
INGREDIENTS (8)
ACETAMINOPHENActive
Quantity: 300 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CODEINE PHOSPHATEActive
Quantity: 60 mg in 1 1
Code: GSL05Y1MN6
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
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
acetaminophen and codeine phosphate
PRODUCT DETAILS
NDC Product Code21695-242
Application NumberANDA040419
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 1, 2009
Generic Nameacetaminophen and codeine phosphate
INGREDIENTS (8)
ACETAMINOPHENActive
Quantity: 300 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CODEINE PHOSPHATEActive
Quantity: 30 mg in 1 1
Code: GSL05Y1MN6
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT