Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and Acetaminophen Oral Solution (7.5 mg/325 mg per 15 mL) CII
Approved
Approval ID
26242cd7-1dbe-4ca4-88ca-5b98a6566ff9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 18, 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
NDC Product Code64950-343
Application NumberANDA040894
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 18, 2023
Generic Namehydrocodone bitartrate and acetaminophen
INGREDIENTS (15)
hydrocodone bitartrateActive
Quantity: 7.5 mg in 15 mL
Code: NO70W886KK
Classification: ACTIB
acetaminophenActive
Quantity: 325 mg in 15 mL
Code: 362O9ITL9D
Classification: ACTIB
D&C red no. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
FD&C Red no. 40Inactive
Code: WZB9127XOA
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITOL SOLUTIONInactive
Code: 8KW3E207O2
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
ETHYL MALTOLInactive
Code: L6Q8K29L05
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT