Oxycodone Hydrochloride

Product NDC
50383-964
11-digit product format
503830964
Labeler code
50383
Product ID
50383-964_464e00c0-eb47-483c-861c-3a483f455b62
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Akorn
Application
ANDA208795
Marketing category
ANDA
Marketing start
2017-08-07
Marketing end
0000-00-00
Substance
OXYCODONE HYDROCHLORIDE
Active strength
100 mg/5mL
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
50383-964-302025-09-11C16284748780-11030e365-48f0-111a-e063-dadaa90a10e21514b5b1-ecd9-406b-bac0-0aa14097bc65
50383-964-302024-01-30C16284748780-11030e365-48f0-111a-e063-dadaa90a10e21514b5b1-ecd9-406b-bac0-0aa14097bc65

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-964-30ML - Milliliter50383-9648c14dcbe-3173-42f5-84d8-7ff0b8cf82bf12018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-964OXYCODONE HYDROCHLORIDE SOLUTION [AKORN]11Legacy NDC20221112_1514b5b1-ecd9-406b-bac0-0aa14097bc65.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50383-964-30503830964301 BOTTLE in 1 CARTON (50383-964-30) > 30 mL in 1 BOTTLE1 bottle2017-08-080000-00-00NoNoCurrent