OXYMORPHONE HYDROCHLORIDE

Product NDC
63629-1925
11-digit product format
636291925
Labeler code
63629
Product ID
63629-1925_5cbea70e-1c53-4786-8110-7cbf31264cb4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXYMORPHONE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210175
Marketing category
ANDA
Marketing start
2018-03-01
Marketing end
0000-00-00
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
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
63629-1925-1EA - Each63629-1925d0dfe856-16d1-45f7-84d3-e0c75f22de9112021-03-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1925-163629192501100 TABLET in 1 BOTTLE (63629-1925-1) 100 tablet2021-01-140000-00-00NoNoCurrent