Oxycodone Hydrochloride

Product NDC
68094-801
11-digit product format
680940801
Labeler code
68094
Product ID
68094-801_5c4b8bc3-0b21-4d33-b8ac-53770f1635a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Precision Dose, Inc.
Application
ANDA204092
Marketing category
ANDA
Marketing start
2016-07-01
Marketing end
2023-11-30
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
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-801-01EA - Each68094-801609b28f1-6a6d-4a3b-b5ab-0e81c8a9316612016-09-02
68094-801-58EA - Each68094-801b5825233-d853-4f12-aa55-23f2cdfce20612016-09-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68094-801-586809408015850 BAG in 1 CASE (68094-801-58) > 1 SYRINGE in 1 BAG > .5 mL in 1 SYRINGE (68094-801-01) 50 bag2016-07-012023-11-30NoNoCurrent