Oxycodone and Acetaminophen
Oxycodone and Acetaminophen Tablets, USP 5 mg / 325 mg CII
Approved
Approval ID
26c17ac7-64f4-436b-a56d-38d4584959e8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 18, 2010
Manufacturers
FDA
Blenheim Pharmacal, Inc.
DUNS: 171434587
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 Code10544-621
Application NumberANDA040777
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxycodone and Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateOctober 18, 2010
FDA Product Classification
INGREDIENTS (9)
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
OXYCODONEActive
Quantity: 5 mg in 1 1
Code: CD35PMG570
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT