FDA.reportPublic FDA data

RECOTHROM

Product NDC
65293-007
11-digit product format
652930007
Labeler code
65293
Product ID
65293-007_b62b217c-4f03-44cf-b038-84bbc84c9179
Type
PLASMA DERIVATIVE
Nonproprietary name
Thrombin topical Recombinant
Dosage form
KIT
Labeler
The Medicines Company
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
2017-12-31
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 productproduct65293-007IInactivated by FDA2026-07-31
excluded packagepackage65293-00765293-007-41IInactivated by FDA2026-07-31
excluded packagepackage65293-00765293-007-50IInactivated by FDA2026-07-31

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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65293-007-412019-11-27C16284748780-19855e2a2-441f-60a7-e053-dbdaa90a05bdThese 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: 2008
65293-007-502019-11-27C16284748780-19855e2a2-441f-60a7-e053-dbdaa90a05bdThese 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: 2008

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65293-007-41RECOTHROM1 in 1 KITKIT18
65293-007-50RECOTHROM1 in 1 KITKIT18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65293-007-41EA - Each65293-0070922fdfe-9e72-4648-ad19-6b6b6cd7db7012015-02-02
65293-007-50EA - Each65293-0079034dff5-cff5-4c9c-bab0-ea45dedf38db12015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
THROMBIN ALFAACTIVE INGREDIENTSCK81AMR7RRECOTHROM (THROMBIN TOPICAL RECOMBINANT) KIT [THE MEDICINES COMPANY]8
THROMBIN ALFAACTIVE MOIETYSCK81AMR7RRECOTHROM (THROMBIN TOPICAL RECOMBINANT) KIT [THE MEDICINES COMPANY]8
CALCIUM CHLORIDEINACTIVE INGREDIENTM4I0D6VV5MRECOTHROM (THROMBIN TOPICAL RECOMBINANT) KIT [THE MEDICINES COMPANY]8
HISTIDINEINACTIVE INGREDIENT4QD397987ERECOTHROM (THROMBIN TOPICAL RECOMBINANT) KIT [THE MEDICINES COMPANY]8
MANNITOLINACTIVE INGREDIENT3OWL53L36ARECOTHROM (THROMBIN TOPICAL RECOMBINANT) KIT [THE MEDICINES COMPANY]8
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PRECOTHROM (THROMBIN TOPICAL RECOMBINANT) KIT [THE MEDICINES COMPANY]8
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XRECOTHROM (THROMBIN TOPICAL RECOMBINANT) KIT [THE MEDICINES COMPANY]8
SUCROSEINACTIVE INGREDIENTC151H8M554RECOTHROM (THROMBIN TOPICAL RECOMBINANT) KIT [THE MEDICINES COMPANY]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65293-007RECOTHROM (THROMBIN TOPICAL RECOMBINANT) KIT [THE MEDICINES COMPANY]8Legacy NDC, 2 package rows20140917_bcf44467-b1eb-479b-8866-a8ac2c780c22.zip

Purple Book Biologic Products#

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1367420Recothrom 1000 UNT in 1 ML Topical SolutionPSNbcf44467-b1eb-479b-8866-a8ac2c780c228
1367418thrombin alfa 1000 UNT in 1 ML Topical SolutionPSNbcf44467-b1eb-479b-8866-a8ac2c780c228
1367420thrombin alfa 1000 UNT/ML Topical Solution [Recothrom]SBDbcf44467-b1eb-479b-8866-a8ac2c780c228
1367418thrombin alfa 1000 UNT/ML Topical SolutionSCDbcf44467-b1eb-479b-8866-a8ac2c780c228
1367418alfa-thrombin 1000 UNT/ML Topical SolutionSYbcf44467-b1eb-479b-8866-a8ac2c780c228
1367420Recothrom 1000 UNT per 1 ML Topical SolutionSYbcf44467-b1eb-479b-8866-a8ac2c780c228
1367420Recothrom 1000 UNT/ML (as alfa-thrombin) Topical SolutionSYbcf44467-b1eb-479b-8866-a8ac2c780c228
1367420Recothrom 20,000 UNT per 20 ML Topical SolutionSYbcf44467-b1eb-479b-8866-a8ac2c780c228
1367420Recothrom 5,000 UNT per 5 ML Topical SolutionSYbcf44467-b1eb-479b-8866-a8ac2c780c228
1367418thrombin alfa 1000 UNT per 1 ML Topical SolutionSYbcf44467-b1eb-479b-8866-a8ac2c780c228
1367418thrombin alfa 20,000 UNT per 20 ML Topical SolutionSYbcf44467-b1eb-479b-8866-a8ac2c780c228

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
65293-007-41652930007411 in 1 KITHistorical
65293-007-50652930007501 in 1 KITHistorical