Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and Acetaminophen Oral Solution CII
Approved
Approval ID
c29b97e9-8097-4d87-a420-ccf5aec8274a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 6, 2023
Manufacturers
FDA
PAI Holdings, LLC
DUNS: 044940096
Products 4
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 Code0121-2316
Application NumberANDA040838
Product Classification
M
Marketing Category
C73584
G
Generic Name
HYDROCODONE BITARTRATE and ACETAMINOPHEN
Product Specifications
Route of AdministrationORAL
Effective DateJuly 6, 2023
FDA Product Classification
INGREDIENTS (12)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
HYDROCODONE BITARTRATEActive
Quantity: 7.5 mg in 15 mL
Code: NO70W886KK
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 325 mg in 15 mL
Code: 362O9ITL9D
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
HYDROCODONE BITARTRATE and ACETAMINOPHEN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0121-4772
Application NumberANDA040838
Product Classification
M
Marketing Category
C73584
G
Generic Name
HYDROCODONE BITARTRATE and ACETAMINOPHEN
Product Specifications
Route of AdministrationORAL
Effective DateJuly 6, 2023
FDA Product Classification
INGREDIENTS (12)
HYDROCODONE BITARTRATEActive
Quantity: 2.5 mg in 5 mL
Code: NO70W886KK
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 108 mg in 5 mL
Code: 362O9ITL9D
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
HYDROCODONE BITARTRATE and ACETAMINOPHEN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0121-1544
Application NumberANDA040838
Product Classification
M
Marketing Category
C73584
G
Generic Name
HYDROCODONE BITARTRATE and ACETAMINOPHEN
Product Specifications
Route of AdministrationORAL
Effective DateJuly 6, 2023
FDA Product Classification
INGREDIENTS (12)
HYDROCODONE BITARTRATEActive
Quantity: 5 mg in 10 mL
Code: NO70W886KK
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 217 mg in 10 mL
Code: 362O9ITL9D
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
HYDROCODONE BITARTRATE and ACETAMINOPHEN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0121-0772
Application NumberANDA040838
Product Classification
M
Marketing Category
C73584
G
Generic Name
HYDROCODONE BITARTRATE and ACETAMINOPHEN
Product Specifications
Route of AdministrationORAL
Effective DateJuly 6, 2023
FDA Product Classification
INGREDIENTS (12)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCODONE BITARTRATEActive
Quantity: 7.5 mg in 15 mL
Code: NO70W886KK
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 325 mg in 15 mL
Code: 362O9ITL9D
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT