Oxycodone and Acetaminophen

Product NDC
0603-4978
11-digit product format
006034978
Labeler code
0603
Product ID
0603-4978_fbadb8bd-f6ea-4fca-ab7d-a3aaad7abcaa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone hydrochloride and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Par Pharmaceutical, Inc.
Application
ANDA090733
Marketing category
ANDA
Marketing start
2013-07-11
Marketing end
2021-10-31
Substance
OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active strength
3 mg/1; mg/1
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
0603-4978-21EA - Each0603-49785f25761d-a122-4241-96f4-dc07209b35d512013-10-17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0603-4978-2100603497821100 TABLET in 1 BOTTLE, PLASTIC (0603-4978-21) 100 tablet2013-07-110000-00-00NoNoCurrent