OXYCODONE HYDROCHLORIDE

Product NDC
61919-820
11-digit product format
619190820
Labeler code
61919
Product ID
61919-820_98ceed10-20d6-5f7b-e053-2995a90aea72
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXYCODONE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA203638
Marketing category
ANDA
Marketing start
2019-06-05
Marketing end
0000-00-00
Substance
OXYCODONE HYDROCHLORIDE
Active strength
15 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
C1ENJ2TE6COXYCODONE HYDROCHLORIDE124-90-3OXYCODONE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-820-306191908203030 TABLET in 1 BOTTLE (61919-820-30) 30 tablet2019-06-050000-00-00NoNoCurrent
61919-820-906191908209090 TABLET in 1 BOTTLE (61919-820-90) 90 tablet2019-08-210000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
OXYCODONE HYDROCHLORIDEDirect_Rx2019-12-03HUMAN PRESCRIPTION DRUG LABEL2
OXYCODONE HYDROCHLORIDEDirect_Rx2019-08-21HUMAN PRESCRIPTION DRUG LABEL1