FDA.reportPublic FDA data

RECOTHROM

Product NDC
43825-707
11-digit product format
438250707
Labeler code
43825
Product ID
43825-707_bd410b51-2420-4b39-acef-397e3664a3ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Thrombin topical Recombinant
Dosage form
KIT
Labeler
Mallinckrodt Hospital Products Inc.
Application
BLA125248
Marketing category
BLA
Marketing start
2008-06-09
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43825-707DDiscontinued by firm2026-07-31
excluded packagepackage43825-70743825-707-41DDiscontinued by firm2026-07-31
excluded packagepackage43825-70743825-707-50DDiscontinued by firm2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
application number: BLA125248

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43825-707-41EA - Each43825-707ee52f070-45a3-4c2b-9713-b6fd843e4de912017-04-05
43825-707-50EA - Each43825-70784ec0c56-d2e5-4656-a032-e7f34feee34f12017-04-05

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125248RecothromThrombin topical (Recombinant)351(a)Rx2026-06-01