Oxycodone and Acetaminophen

Product NDC
0904-6437
11-digit product format
009046437
Labeler code
0904
Product ID
0904-6437_3e21529e-fa93-49b4-bc1c-ecd2a9a505e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone hydrochloride and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA040105
Marketing category
ANDA
Marketing start
1996-07-30
Marketing end
0000-00-00
Substance
OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active strength
5 mg/1; 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
0904-6437-61EA - Each0904-64378840c67a-da9a-4dfa-b6dd-284f1ad8350d12015-11-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6437-6100904643761100 BLISTER PACK in 1 CARTON (0904-6437-61) > 1 TABLET in 1 BLISTER PACK100 blister pack1996-07-300000-00-00NoNoCurrent