FDA.reportPublic FDA data

HYDROcodone bitartrate 2.5 MG / ibuprofen 200 MG Oral Tablet

RxCUI
858770
RxNorm name
HYDROcodone bitartrate 2.5 MG / ibuprofen 200 MG Oral Tablet
Display name
HYDROcodone bitartrate 2.5 MG / ibuprofen 200 MG Oral Tablet
Full name
HYDROcodone bitartrate 2.5 MG / ibuprofen 200 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:15

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocodone Bitartrate and IbuprofenHYDROCODONE BITARTRATE AND IBUPROFENAmneal Pharmaceuticals of New York LLCabc33718-4e88-43ea-9ffa-2b04ffc812ef2025-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 858770

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

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

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
abc33718-4e88-43ea-9ffa-2b04ffc812efHYDROcodone bitartrate 2.5 MG / ibuprofen 200 MG Oral Tablet [PSN] · hydrocodone bitartrate 2.5 MG / ibuprofen 200 MG Oral Tablet [SCD]246Hydrocodone Bitartrate and Ibuprofen Tablets CII (2.5 mg/200 mg , 5 mg/200 mg , 7.5 mg/200 mg & 10 mg/200 mg) Rx Only20251121