FDA.reportPublic FDA data

Abuse-Deterrent 24 HR hydrocodone bitartrate 80 MG Extended Release Oral Tablet

RxCUI
1595758
RxNorm name
Abuse-Deterrent 24 HR hydrocodone bitartrate 80 MG Extended Release Oral Tablet
Display name
Abuse-Deterrent 24 HR hydrocodone bitartrate 80 MG Extended Release Oral Tablet
Full name
Abuse-Deterrent 24 HR hydrocodone bitartrate 80 MG Extended Release Oral Tablet
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:17

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#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hysingla ERHYDROCODONE BITARTRATEKnoa Pharma LLCb7d23ac2-e776-9f62-3290-c64c2d6eb3532026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1595758
Hydrocodone BitartrateHYDROCODONE BITARTRATEAlvogen Inc.f7b55d14-0980-b680-8ceb-7489ff65455e2025-10-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1595758

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
b7d23ac2-e776-9f62-3290-c64c2d6eb353hydrocodone bitartrate 80 MG 24 HR Extended Release Oral Tablet, Abuse-DeterrentSY16These highlights do not include all the information needed to use HYSINGLA ® ER safely and effectively. See full prescribing information for HYSINGLA ER. HYSINGLA ® ER (hydrocodone bitartrate) extended-release tablets, for oral use, CII Initial U.S. Approval: 194320260501
b7d23ac2-e776-9f62-3290-c64c2d6eb353HYDROcodone bitartrate 80 MG 24HR Extended Release Oral Tablet, Abuse-DeterrentPSN16These highlights do not include all the information needed to use HYSINGLA ® ER safely and effectively. See full prescribing information for HYSINGLA ER. HYSINGLA ® ER (hydrocodone bitartrate) extended-release tablets, for oral use, CII Initial U.S. Approval: 194320260501
b7d23ac2-e776-9f62-3290-c64c2d6eb353Abuse-Deterrent 24 HR hydrocodone bitartrate 80 MG Extended Release Oral TabletSCD16These highlights do not include all the information needed to use HYSINGLA ® ER safely and effectively. See full prescribing information for HYSINGLA ER. HYSINGLA ® ER (hydrocodone bitartrate) extended-release tablets, for oral use, CII Initial U.S. Approval: 194320260501
f7b55d14-0980-b680-8ceb-7489ff65455ehydrocodone bitartrate 80 MG 24 HR Extended Release Oral Tablet, Abuse-DeterrentSY8These highlights do not include all the information needed to use HYDROCODONE BITARTRATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for HYDROCODONE BITARTRATE EXTENDED-RELEASE TABLETS. HYDROCODONE BITARTRATE extended-release tablets, for oral use, CII Initial U.S. Approval: 194320251007
f7b55d14-0980-b680-8ceb-7489ff65455eHYDROcodone bitartrate 80 MG 24HR Extended Release Oral Tablet, Abuse-DeterrentPSN8These highlights do not include all the information needed to use HYDROCODONE BITARTRATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for HYDROCODONE BITARTRATE EXTENDED-RELEASE TABLETS. HYDROCODONE BITARTRATE extended-release tablets, for oral use, CII Initial U.S. Approval: 194320251007
f7b55d14-0980-b680-8ceb-7489ff65455eAbuse-Deterrent 24 HR hydrocodone bitartrate 80 MG Extended Release Oral TabletSCD8These highlights do not include all the information needed to use HYDROCODONE BITARTRATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for HYDROCODONE BITARTRATE EXTENDED-RELEASE TABLETS. HYDROCODONE BITARTRATE extended-release tablets, for oral use, CII Initial U.S. Approval: 194320251007