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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27808-115
Application NumberANDA202214
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocodone Bitartrate and Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateAugust 14, 2021
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27808-116
Application NumberANDA202214
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocodone Bitartrate and Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateAugust 14, 2021
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27808-114
Application NumberANDA202214
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocodone Bitartrate and Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateAugust 14, 2021
FDA Product Classification
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