Hydrocodone Bitartrate and Acetaminophen
y
Approved
Approval ID
d8fe4ae4-bd19-42eb-b74d-f302b3f914ee
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 3, 2023
Manufacturers
FDA
Tris Pharma Inc
DUNS: 947472119
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydrocodone Bitartrate and Acetaminophen
PRODUCT DETAILS
NDC Product Code27808-115
Application NumberANDA202214
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 14, 2021
Generic NameHydrocodone Bitartrate and Acetaminophen
INGREDIENTS (2)
HYDROCODONE BITARTRATEActive
Quantity: 7.5 mg in 1 1
Code: NO70W886KK
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 300 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
Hydrocodone Bitartrate and Acetaminophen
PRODUCT DETAILS
NDC Product Code27808-116
Application NumberANDA202214
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 14, 2021
Generic NameHydrocodone Bitartrate and Acetaminophen
INGREDIENTS (2)
HYDROCODONE BITARTRATEActive
Quantity: 10 mg in 1 1
Code: NO70W886KK
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 300 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
Hydrocodone Bitartrate and Acetaminophen
PRODUCT DETAILS
NDC Product Code27808-114
Application NumberANDA202214
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 14, 2021
Generic NameHydrocodone Bitartrate and Acetaminophen
INGREDIENTS (7)
HYDROCODONE BITARTRATEActive
Quantity: 5 mg in 1 1
Code: NO70W886KK
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 300 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUMInactive
Code: I38ZP9992A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT