Oxycodone and Acetaminophen

Product NDC
68084-355
11-digit product format
680840355
Labeler code
68084
Product ID
68084-355_d540b8a6-0801-191e-e053-2995a90af7d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA040777
Marketing category
ANDA
Marketing start
2009-09-10
Marketing end
2022-11-30
Substance
OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active strength
5 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-355-01EA - Each68084-3554c1d07be-5fc2-453c-8aef-3c8e918a09df12012-07-24
68084-355-11EA - Each68084-355475cc14b-5173-43ed-ab7e-d032a4a72ed312012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-355-0168084035501100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-355-01) > 1 TABLET in 1 BLISTER PACK (68084-355-11) 100 blister pack2009-09-100000-00-00NoNoCurrent