Oxycodone Hydrochloride

Product NDC
63629-8889
11-digit product format
636298889
Labeler code
63629
Product ID
63629-8889_dc52295f-674a-47ff-888c-fca789957996
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207418
Marketing category
ANDA
Marketing start
2017-08-08
Marketing end
0000-00-00
Substance
OXYCODONE HYDROCHLORIDE
Active strength
15 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8889-1EA - Each63629-8889d775819e-b354-438e-a53a-7eee4124d1e412021-12-08
63629-8889-2EA - Each63629-8889287720db-e7e0-4675-8bc9-dfdfd1f297ad12021-12-08
63629-8889-4EA - Each63629-8889eebd5882-acec-463a-9c51-4249c7d1502512021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8889OXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]101Legacy NDC20231027_7ec1ff9d-221f-463e-b2d4-5a0360b9c4d2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8889-16362988890130 TABLET in 1 BOTTLE (63629-8889-1) 30 tablet2021-10-210000-00-00NoNoCurrent
63629-8889-26362988890260 TABLET in 1 BOTTLE (63629-8889-2) 60 tablet2021-10-210000-00-00NoNoCurrent
63629-8889-36362988890390 TABLET in 1 BOTTLE (63629-8889-3) 90 tablet2021-10-210000-00-00NoNoCurrent
63629-8889-463629888904120 TABLET in 1 BOTTLE (63629-8889-4) 120 tablet2021-10-210000-00-00NoNoCurrent