Oxycodone Hydrochloride

Product NDC
0904-6445
11-digit product format
009046445
Labeler code
0904
Product ID
0904-6445_fc4168a8-9f14-4b6a-a0b6-39716e9c463d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA077290
Marketing category
ANDA
Marketing start
2015-06-01
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6445-61EA - Each0904-644516ca7789-366f-4731-8441-e44130d60cca12015-11-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6445-6100904644561100 TABLET in 1 BOX, UNIT-DOSE (0904-6445-61) 100 tablet2015-06-010000-00-00NoNoCurrent