Oxycodone and Acetaminophen

Product NDC
63739-709
11-digit product format
637390709
Labeler code
63739
Product ID
63739-709_aace044e-43c8-4fde-b336-1a492217893f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
McKesson Corporation dba SKY Packaging
Application
ANDA040777
Marketing category
ANDA
Marketing start
2007-11-27
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63739-709-102020-07-22C16284748780-1ab0e2407-293b-f274-e053-dbdaa90a647191b641e0-4e89-41c0-9696-b961d79783c8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-709-10EA - Each63739-709878dbcd0-4c6a-4b8a-9191-371c5c5d09f512016-06-14