Oxycodone Hydrochloride

Product NDC
66689-401
11-digit product format
666890401
Labeler code
66689
Product ID
66689-401_6f0d315a-4d02-4548-b993-ba648c596bc3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
VistaPharm, Inc.
Application
NDA201194
Marketing category
NDA
Marketing start
2012-03-15
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
66689-401-502024-01-30C16284748780-11030e364-fb51-111a-e063-dadaa90a10e2d7dceba3-96dc-4593-bc8f-318052bdb520

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66689-401-01ML - Milliliter66689-401dc97b601-7870-4390-bd53-4ac15acfdb2b12012-07-24
66689-401-50ML - Milliliter66689-401b59ec39e-d4a4-48ac-8af9-69f5ed9c1b8d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.]1
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLOXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAOXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXOXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.]1
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGOXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUOXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25ROXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.]1
WATERINACTIVE INGREDIENT059QF0KO0ROXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66689-401OXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM, LLC]24Legacy NDC20240427_d7dceba3-96dc-4593-bc8f-318052bdb520.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66689-401-50666890401505 TRAY in 1 CASE (66689-401-50) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (66689-401-01) 5 tray2012-03-150000-00-00NoNoCurrent