FDA.reportPublic FDA data

thrombin alfa 1000 UNT per 1 ML Topical Solution

RxCUI
1367418
RxNorm name
thrombin alfa 1000 UNT per 1 ML Topical Solution
Display name
thrombin alfa 1000 UNT per 1 ML Topical Solution
Full name
thrombin alfa 1000 UNT per 1 ML Topical Solution
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:58

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125248RecothromThrombin topical (Recombinant)351(a)Rx2026-08-01

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
RECOTHROMTHROMBIN TOPICAL RECOMBINANTBaxter Healthcare Corporation54885644-e51e-4263-aadb-366abaeb56a32025-06-09Warnings, Adverse reactionsExact identifier
rxcui: 1367418

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 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
54885644-e51e-4263-aadb-366abaeb56a3thrombin alfa 1000 UNT in 1 ML Topical Solution [PSN] · thrombin alfa 1000 UNT/ML Topical Solution [SCD] · alfa-thrombin 1000 UNT/ML Topical Solution [SY] · thrombin alfa 1000 UNT per 1 ML Topical Solution [SY] · thrombin alfa 20,000 UNT per 20 ML Topical Solution [SY]515These highlights do not include all the information needed to use RECOTHROM safely and effectively. See full prescribing information for RECOTHROM. RECOTHROM Thrombin topical (Recombinant) Lyophilized Powder for Solution – For Topical Use Only Initial U.S. Approval: 200820250609
bcf44467-b1eb-479b-8866-a8ac2c780c22thrombin alfa 1000 UNT in 1 ML Topical Solution [PSN] · thrombin alfa 1000 UNT/ML Topical Solution [SCD] · alfa-thrombin 1000 UNT/ML Topical Solution [SY] · thrombin alfa 1000 UNT per 1 ML Topical Solution [SY] · thrombin alfa 20,000 UNT per 20 ML Topical Solution [SY]58These highlights do not include all the information needed to use RECOTHROM safely and effectively. See full prescribing information for RECOTHROM. RECOTHROM, Thrombin topical (Recombinant) Lyophilized Powder for Solution - For Topical Use Only Initial U.S. Approval: 200820140910