OXYMORPHONE HYDROCHLORIDE

Product NDC
0406-1010
11-digit product format
004061010
Labeler code
0406
Product ID
0406-1010_0c2957c6-5714-416c-9afb-98ee965950f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxymorphone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
SpecGx LLC
Application
ANDA202321
Marketing category
ANDA
Marketing start
2013-04-25
Marketing end
2021-05-31
Substance
OXYMORPHONE HYDROCHLORIDE
Active strength
10 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
0406-1010-01EA - Each0406-101027e52e8f-25e2-4390-84d7-d786f1629a5b12013-08-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0406-1010-0100406101001100 TABLET in 1 BOTTLE (0406-1010-01) 100 tablet2013-04-252021-05-31NoNoCurrent