Hydrocodone Bitartrate and Acetaminophen
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CII 5 mg/325 mg, 7.5 mg/325 mg, 10 mg/325 mg Rx only
Approved
Approval ID
ba7d27eb-952d-4e99-95b9-5b0b2f85794b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 24, 2025
Manufacturers
FDA
Asclemed USA, Inc.
DUNS: 059888437
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 Code76420-875
Application NumberANDA202214
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 24, 2025
Generic NameHydrocodone Bitartrate and Acetaminophen
INGREDIENTS (7)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
HYDROCODONE BITARTRATEActive
Quantity: 5 mg in 1 1
Code: NO70W886KK
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
Hydrocodone Bitartrate and Acetaminophen
PRODUCT DETAILS
NDC Product Code76420-877
Application NumberANDA202214
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 24, 2025
Generic NameHydrocodone Bitartrate and Acetaminophen
INGREDIENTS (2)
HYDROCODONE BITARTRATEActive
Quantity: 10 mg in 1 1
Code: NO70W886KK
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
Hydrocodone Bitartrate and Acetaminophen
PRODUCT DETAILS
NDC Product Code76420-876
Application NumberANDA202214
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 24, 2025
Generic NameHydrocodone Bitartrate and Acetaminophen
INGREDIENTS (2)
HYDROCODONE BITARTRATEActive
Quantity: 7.5 mg in 1 1
Code: NO70W886KK
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB