Nalocet
Nalocet
Approved
Approval ID
f5f7dfca-a5c7-4445-8a5e-9ec62f33f5be
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
Forte Bio-Pharma LLC
DUNS: 081161340
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
oxycodone and acetaminophen
PRODUCT DETAILS
NDC Product Code72245-193
Application NumberANDA040608
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 9, 2024
Generic Nameoxycodone and acetaminophen
INGREDIENTS (10)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ACETAMINOPHENActive
Quantity: 300 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
OXYCODONE HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT