FDA.reportPublic FDA data

24 HR hydromorphone hydrochloride 16 MG Extended Release Oral Tablet

RxCUI
902736
RxNorm name
24 HR hydromorphone hydrochloride 16 MG Extended Release Oral Tablet
Display name
24 HR hydromorphone hydrochloride 16 MG Extended Release Oral Tablet
Full name
24 HR hydromorphone hydrochloride 16 MG Extended Release Oral Tablet
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:07

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDETrigen Laboratories, LLC8bb81796-6990-40e9-bee4-1f292f91ae992025-12-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 902736
hydromorphone hydrochlorideHYDROMORPHONE HYDROCHLORIDEPadagis US LLC780a2616-0392-4715-bc50-71799bea19572025-12-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 902736
hydromorphone hydrochlorideHYDROMORPHONE HYDROCHLORIDECamber Pharmaceuticals, Inc.c33e6320-4206-4b69-8cac-ebfc2351b8f22025-08-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 902736
hydromorphone hydrochlorideHYDROMORPHONE HYDROCHLORIDEXLCare Pharmaceuticals, Inc.90bda45c-9dbe-4ed5-91d0-df8446ad70262024-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 902736

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 5 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
8bb81796-6990-40e9-bee4-1f292f91ae99HYDROmorphone HCl 16 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR hydromorphone hydrochloride 16 MG Extended Release Oral Tablet [SCD] · hydromorphone hydrochloride 16 MG 24 HR Extended Release Oral Tablet [SY]329These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. HYDROMORPHONE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 198420251225
780a2616-0392-4715-bc50-71799bea1957HYDROmorphone HCl 16 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR hydromorphone hydrochloride 16 MG Extended Release Oral Tablet [SCD] · hydromorphone hydrochloride 16 MG 24 HR Extended Release Oral Tablet [SY]320These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. HYDROMORPHONE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 198420251222
c33e6320-4206-4b69-8cac-ebfc2351b8f2HYDROmorphone HCl 16 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR hydromorphone hydrochloride 16 MG Extended Release Oral Tablet [SCD] · hydromorphone hydrochloride 16 MG 24 HR Extended Release Oral Tablet [SY]33These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. HYDROMORPHONE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 198420250818
90bda45c-9dbe-4ed5-91d0-df8446ad7026HYDROmorphone HCl 16 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR hydromorphone hydrochloride 16 MG Extended Release Oral Tablet [SCD] · hydromorphone hydrochloride 16 MG 24 HR Extended Release Oral Tablet [SY]33These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. HYDROMORPHONE HYDROCHLORIDE extended-release tablets, for oral use, CII Initial U.S. Approval: 198420240117
0dedd480-dc5c-499c-8763-6044b9bd4a6bHYDROmorphone HCl 16 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR hydromorphone hydrochloride 16 MG Extended Release Oral Tablet [SCD] · hydromorphone hydrochloride 16 MG 24 HR Extended Release Oral Tablet [SY]31These highlights do not include all the information needed to use EXALGO ® safely and effectively. See full prescribing information for EXALGO. EXALGO (hydromorphone HCl) Extended-Release Tablets, for oral use, CII Initial U.S. Approval: 198420130128