HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Hydrocodone Bitartrate and Acetaminophen Tablets USP CII 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg Revised: NOVEMBER 2023
Approved
Approval ID
73c1059b-0c7d-42ef-9827-f018858fc447
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 3, 2024
Manufacturers
FDA
SpecGx LLC
DUNS: 080679498
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 Code0406-0125
Application NumberANDA040400
Product Classification
M
Marketing Category
C73584
G
Generic Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 3, 2024
FDA Product Classification
INGREDIENTS (9)
HYDROCODONE BITARTRATEActive
Quantity: 10 mg in 1 1
Code: NO70W886KK
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0406-0123
Application NumberANDA040409
Product Classification
M
Marketing Category
C73584
G
Generic Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 3, 2024
FDA Product Classification
INGREDIENTS (9)
HYDROCODONE BITARTRATEActive
Quantity: 5 mg in 1 1
Code: NO70W886KK
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0406-0124
Application NumberANDA040405
Product Classification
M
Marketing Category
C73584
G
Generic Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 3, 2024
FDA Product Classification
INGREDIENTS (9)
HYDROCODONE BITARTRATEActive
Quantity: 7.5 mg in 1 1
Code: NO70W886KK
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT