Oxycodone Hydrochloride

Product NDC
0121-4839
11-digit product format
001214839
Labeler code
0121
Product ID
0121-4839_d57d9fd8-8252-3c89-e053-2995a90aa9f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Pharmaceutical Associates, Inc.
Application
ANDA206456
Marketing category
ANDA
Marketing start
2016-05-16
Marketing end
0000-00-00
Substance
OXYCODONE HYDROCHLORIDE
Active strength
5 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
0121-4839-402023-11-03C16284748780-10191ceaa-6f5a-198a-e063-dbdaa90aec3e873f9a0a-2f28-43c3-8d28-c8c87e9af3b1
0121-4839-402023-07-28C16284748780-10191ceaa-6f5a-198a-e063-dbdaa90aec3e873f9a0a-2f28-43c3-8d28-c8c87e9af3b1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-4839-05ML - Milliliter0121-4839e1c70e09-ebfc-4a49-b5aa-50b52032760e12016-07-19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-4839-40001214839404 TRAY in 1 CASE (0121-4839-40) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (0121-4839-05) 4 tray2016-05-160000-00-00NoNoCurrent