Oxymorphone Hydrochloride

Product NDC
35356-967
11-digit product format
353560967
Labeler code
35356
Product ID
35356-967_a6d134e4-52fd-42f2-8740-20332fb3b614
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxymorphone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA203601
Marketing category
ANDA
Marketing start
2013-02-11
Marketing end
0000-00-00
Substance
OXYMORPHONE HYDROCHLORIDE
Active strength
5 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
35356-967-302022-08-29C16284748780-1d6a99b39-ccc0-a426-e053-dadaa90af4c282cc28da-27d1-4d29-83ab-e6719e49750d
35356-967-302022-01-28C16284748780-1d6a99b39-ccc0-a426-e053-dadaa90af4c282cc28da-27d1-4d29-83ab-e6719e49750d

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35356-967-30EA - Each35356-967e8c31c8c-06ed-46f9-899c-4552f48b343a12013-11-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35356-967-303535609673030 TABLET in 1 BOTTLE (35356-967-30) 30 tablet2013-02-110000-00-00NoNoCurrent