Oxymorphone hydrochloride

Product NDC
55700-788
11-digit product format
557000788
Labeler code
55700
Product ID
55700-788_1dd752f7-eb2e-4395-a646-418939def683
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxymorphone hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA079087
Marketing category
ANDA
Marketing start
2019-08-30
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55700-788-602025-01-10C16284748780-11030e364-fe3b-111a-e063-dadaa90a10e2fe6eea77-a178-4df0-b93c-e5c07457d69f
55700-788-602024-01-30C16284748780-11030e364-fe3b-111a-e063-dadaa90a10e2fe6eea77-a178-4df0-b93c-e5c07457d69f

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-788-60EA - Each55700-7880b730637-5b2b-44bd-9597-07965768b50d12019-10-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-788-605570007886060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55700-788-60) 2021-02-110000-00-00NoNoCurrent