Oxycodone and Acetaminophen

Product NDC
63629-1911
11-digit product format
636291911
Labeler code
63629
Product ID
63629-1911_3064a4a0-768e-41b3-b67e-8c85d0bf5a48
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
63629-1911-1EA - Each63629-1911446c3b3d-de56-48e1-ab39-701c2dcce44212021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1911OXYCODONE AND ACETAMINOPHEN TABLET [BRYANT RANCH PREPACK]105Legacy NDC20240502_959485dc-d67f-4d6f-9f32-1d0f7dfe2b2a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1911-163629191101100 TABLET in 1 BOTTLE (63629-1911-1) 100 tablet2019-03-150000-00-00NoNoCurrent