Oxycodone and Acetaminophen

Product NDC
68071-4852
11-digit product format
680714852
Labeler code
68071
Product ID
68071-4852_bb8fff22-c6c9-4620-e053-2995a90ae117
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA207419
Marketing category
ANDA
Marketing start
2017-04-11
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4852-26807148520220 TABLET in 1 BOTTLE (68071-4852-2) 20 tablet2019-04-170000-00-00NoNoCurrent