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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64950-343
Application NumberANDA040894
Product Classification
M
Marketing Category
C73584
G
Generic Name
hydrocodone bitartrate and acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateOctober 18, 2023
FDA Product Classification
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