Oxycodone and Acetaminophen

Product NDC
55700-373
11-digit product format
557000373
Labeler code
55700
Product ID
55700-373_5a2a44d9-fe78-4735-994b-a47bbbf11ead
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA040778
Marketing category
ANDA
Marketing start
2013-11-01
Marketing end
0000-00-00
Substance
OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active strength
8 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record