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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-243
Application NumberANDA040419
Product Classification
M
Marketing Category
C73584
G
Generic Name
acetaminophen and codeine phosphate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2009
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-242
Application NumberANDA040419
Product Classification
M
Marketing Category
C73584
G
Generic Name
acetaminophen and codeine phosphate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2009
FDA Product Classification
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