FDA.reportPublic FDA data

Prolate (acetaminophen 300 MG / oxycodone HCl 7.5 MG) Oral Tablet

RxCUI
2279514
RxNorm name
Prolate (acetaminophen 300 MG / oxycodone HCl 7.5 MG) Oral Tablet
Display name
Prolate (acetaminophen 300 MG / oxycodone HCl 7.5 MG) Oral Tablet
Full name
Prolate (acetaminophen 300 MG / oxycodone HCl 7.5 MG) Oral Tablet
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:10

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ProlateOXYCODONE AND ACETAMINOPHENForte Bio-Pharma LLC9cbbfa94-37b9-9652-e053-2995a90a736b2026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2279514

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
9cbbfa94-37b9-9652-e053-2995a90a736bProlate 7.5 / 300 Oral Tablet [PSN] · acetaminophen 300 MG / oxycodone hydrochloride 7.5 MG Oral Tablet [Prolate] [SBD] · APAP 300 MG / Oxycodone Hydrochloride 7.5 MG Oral Tablet [Prolate] [SY] · Prolate (acetaminophen 300 MG / oxycodone HCl 7.5 MG) Oral Tablet [SY]48Prolate ® (Oxycodone and Acetaminophen Tablets, USP)20260302