oxycodone hydrochloride and acetaminophen
Oxycodone Hydrochloride and Acetaminophen Oral Solution
Approved
Approval ID
96b0067e-aabe-df4f-e053-2995a90a4a86
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 1, 2023
Manufacturers
FDA
FH2 Pharma LLC
DUNS: 116969558
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
oxycodone hydrochloride and acetaminophen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72887-648
Application NumberANDA202142
Product Classification
M
Marketing Category
C73584
G
Generic Name
oxycodone hydrochloride and acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2023
FDA Product Classification
INGREDIENTS (12)
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
FRUCTOSEInactive
Code: 6YSS42VSEV
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
ACETAMINOPHENActive
Quantity: 300 mg in 5 mL
Code: 362O9ITL9D
Classification: ACTIB
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
OXYCODONE HYDROCHLORIDEActive
Quantity: 10 mg in 5 mL
Code: C1ENJ2TE6C
Classification: ACTIB