Acetaminophen and Codeine
Acetaminophen and Codeine Phosphate Tablets, USP CIII 300 mg/30 mg Rx Only
Approved
Approval ID
5970383b-06a3-45e7-9e93-41213a4f9b5d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 7, 2023
Manufacturers
FDA
RPK Pharmaceuticals, Inc.
DUNS: 147096275
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acetaminophen and Codeine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53002-0101
Application NumberANDA040779
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acetaminophen and Codeine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 21, 2021
FDA Product Classification
INGREDIENTS (10)
ACETAMINOPHENActive
Quantity: 300 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CODEINE PHOSPHATEActive
Quantity: 30 mg in 1 1
Code: GSL05Y1MN6
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT