OXYCODONE HCl

Product NDC
10702-803
11-digit product format
107020803
Labeler code
10702
Product ID
10702-803_b48ac468-a5e7-4c8e-e053-2a95a90a5fcf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXYCODONE HCl
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
KVK-Tech, Inc.
Application
NDA022272
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2019-04-05
Marketing end
0000-00-00
Substance
OXYCODONE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10702-803-012025-06-17C16284748780-1f386c64a-25c4-0266-e053-dadaa90a7c1ac5b52ff1-21a6-4d28-9982-55b4ac195fac
10702-803-012023-01-30C16284748780-1f386c64a-25c4-0266-e053-dadaa90a7c1ac5b52ff1-21a6-4d28-9982-55b4ac195fac

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10702-803-01EA - Each10702-8031e185e6f-e0b5-44f2-b150-dd2a03480fab12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10702-803OXYCODONE HCL TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]3Legacy NDC20201121_c5b52ff1-21a6-4d28-9982-55b4ac195fac.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10702-803-0110702080301100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10702-803-01) 2019-04-050000-00-00NoNoCurrent