FDA.reportPublic FDA data

Adzenys XR-ODT 12.5 MG 24HR Extended Release Distintegrating Oral Tablet

RxCUI
1739809
RxNorm name
Adzenys XR-ODT 12.5 MG 24HR Extended Release Distintegrating Oral Tablet
Display name
Adzenys XR-ODT 12.5 MG 24HR Extended Release Distintegrating Oral Tablet
Full name
Adzenys XR-ODT 12.5 MG 24HR Extended Release Distintegrating Oral Tablet
Term type
PSN
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: 1739809

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
c1179269-00b5-48ea-972d-31e614e99b7eAdzenys XR-ODT 12.5 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
c1179269-00b5-48ea-972d-31e614e99b7eAdzenys 12.5 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 12.5 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