Oxycodone Hydrochloride

Product NDC
0591-2708
11-digit product format
005912708
Labeler code
0591
Product ID
0591-2708_b216cced-2501-4dd1-a41b-f27dfc186e81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxycodone hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
NDA022272
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-09-03
Marketing end
0000-00-00
Substance
OXYCODONE HYDROCHLORIDE
Active strength
80 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-2708-01EA - Each0591-2708f5a69815-6a66-4883-ac96-9e1193be3d1a12015-02-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0591-2708-0100591270801100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-2708-01) 2014-09-030000-00-00NoNoCurrent