Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL CII
Approved
Approval ID
a9fb9779-76a5-407a-a155-84f198004ae2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 11, 2023
Manufacturers
FDA
Genus Lifesciences Inc.
DUNS: 113290444
Products 1
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 Code64950-373
Application NumberANDA040838
Product Classification
M
Marketing Category
C73584
G
Generic Name
hydrocodone bitartrate and acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateOctober 11, 2023
FDA Product Classification
INGREDIENTS (13)
hydrocodone bitartrateActive
Quantity: 7.5 mg in 15 mL
Code: NO70W886KK
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
acetaminophenActive
Quantity: 325 mg in 15 mL
Code: 362O9ITL9D
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
AlcoholInactive
Code: 3K9958V90M
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FD&C Red no. 40Inactive
Code: WZB9127XOA
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT