Acetaminophen and Codeine Phosphate
LORAZEPAM tablet
Approved
Approval ID
3e41c92a-826d-40af-b2c5-b7720dd32657
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 20, 2011
Manufacturers
FDA
RedPharm Drug Inc.
DUNS: 008039641
Products 1
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 Code67296-0041
Application NumberANDA088628
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acetaminophen and Codeine Phosphate
Product Specifications
Route of AdministrationORAL
Effective DateMay 20, 2011
FDA Product Classification
INGREDIENTS (6)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ACETAMINOPHENActive
Quantity: 300 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CODEINE PHOSPHATEActive
Quantity: 15 mg in 1 1
Code: GSL05Y1MN6
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT