FDA.reportPublic FDA data

Adzenys 6.3 MG 24 HR Extended Release Distintegrating Oral Tablet

RxCUI
1739833
RxNorm name
Adzenys 6.3 MG 24 HR Extended Release Distintegrating Oral Tablet
Display name
Adzenys 6.3 MG 24 HR Extended Release Distintegrating Oral Tablet
Full name
Adzenys 6.3 MG 24 HR Extended Release Distintegrating Oral Tablet
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:19

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Adzenys XR-ODTAMPHETAMINENeos Therapeutics Brands, LLCc1179269-00b5-48ea-972d-31e614e99b7e2026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1739833

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
c1179269-00b5-48ea-972d-31e614e99b7eAdzenys 6.3 MG 24 HR Extended Release Distintegrating Oral TabletSY15These highlights do not include all the information needed to use ADZENYS XR-ODT™ safely and effectively. See full prescribing information for ADZENYS XR-ODT. ADZENYS XR-ODT (amphetamine) extended-release orally disintegrating tablets, CII Initial U.S. Approval: 196020260506
c1179269-00b5-48ea-972d-31e614e99b7e24 HR amphetamine 6.3 MG Extended Release Oral Tablet [Adzenys]SBD15These highlights do not include all the information needed to use ADZENYS XR-ODT™ safely and effectively. See full prescribing information for ADZENYS XR-ODT. ADZENYS XR-ODT (amphetamine) extended-release orally disintegrating tablets, CII Initial U.S. Approval: 196020260506
c1179269-00b5-48ea-972d-31e614e99b7eAdzenys XR-ODT 6.3 MG 24HR Extended Release Distintegrating Oral TabletPSN15These highlights do not include all the information needed to use ADZENYS XR-ODT™ safely and effectively. See full prescribing information for ADZENYS XR-ODT. ADZENYS XR-ODT (amphetamine) extended-release orally disintegrating tablets, CII Initial U.S. Approval: 196020260506