Oxycodone and Acetaminophen
Oxycodone APAP 5mg 325mg
Approved
Approval ID
3f2b939c-2206-469b-85a4-b0ee9ba25be8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 22, 2023
Manufacturers
FDA
Quality Care products LLC
DUNS: 831276758
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49999-852
Application NumberANDA087463
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxycodone and Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateAugust 10, 2022
FDA Product Classification
INGREDIENTS (8)
OXYCODONE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT