Oxycodone and Acetaminophen

Product NDC
63629-1908
11-digit product format
636291908
Labeler code
63629
Product ID
63629-1908_fed1f07e-c9f5-4ef7-a0c8-9ef2bfcdceab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207419
Marketing category
ANDA
Marketing start
2017-04-11
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Active strength
325 mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1908-1EA - Each63629-19085274f307-faf5-48f9-9504-3661239bf5b912021-03-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1908-163629190801500 TABLET in 1 BOTTLE (63629-1908-1) 500 tablet2021-01-140000-00-00NoNoCurrent