OXYCODONE AND ACETAMINOPHEN

Product NDC
63629-1942
11-digit product format
636291942
Labeler code
63629
Product ID
63629-1942_cc6c39b8-e654-43a6-892c-d3fd7747c5a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxycodone and acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207510
Marketing category
ANDA
Marketing start
2019-06-01
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
63629-1942-1EA - Each63629-1942fe1507d1-f8dd-4155-86aa-0d16cbb4d08412021-04-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1942-163629194201500 TABLET in 1 BOTTLE (63629-1942-1) 500 tablet2021-02-100000-00-00NoNoCurrent