oxycodone hydrochloride

Product NDC
0781-5785
11-digit product format
007815785
Labeler code
0781
Product ID
0781-5785_2daac07a-7b11-4e90-bc56-20a4f54fbbf8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxycodone hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Sandoz Inc
Application
NDA022272
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-10-08
Marketing end
0000-00-00
Substance
OXYCODONE HYDROCHLORIDE
Active strength
80 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0781-5785-012020-11-02C16284748780-19d75b9cf-e1d7-f424-e053-dadaa90a57ce2daac07a-7b11-4e90-bc56-20a4f54fbbf8
0781-5785-012020-01-31C16284748780-19d75b9cf-e1d7-f424-e053-dadaa90a57ce2daac07a-7b11-4e90-bc56-20a4f54fbbf8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-5785-01EA - Each0781-578589e14398-6b4e-4b26-bfd4-3bf642e7055d12014-11-05