FDA.reportPublic FDA data

RECOTHROM

Product NDC
0338-0330
11-digit product format
003380330
Labeler code
0338
Product ID
0338-0330_dfa7d1e1-447c-44fb-bcbe-7e01a0c08297
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
thrombin topical recombinant
Dosage form
KIT
Labeler
Baxter Healthcare Corporation
Application
BLA125248
Marketing category
BLA
Marketing start
2008-06-09
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
RECOTHROM
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1367418Internal RxNorm lookup
1367420Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
54885644-e51e-4263-aadb-366abaeb56a3Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0338-0328-01RECOTHROM20 mL in 1 VIALPOWDER, FOR SOLUTION20 mL1000 [iU] in 1mL15
0338-0330-01RECOTHROM1 in 1 KITKIT115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-0330-01EA - Each0338-0330fe68dc09-6a19-423c-9b15-d4b952fd1da912019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-0330RECOTHROM (THROMBIN TOPICAL RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]12Current NDC, Legacy NDC, 2 package rows20240119_54885644-e51e-4263-aadb-366abaeb56a3.zip

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
application number: BLA125248
ndc (product): 0338-0330

Purple Book Biologic Products#

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1367420Recothrom 1000 UNT in 1 ML Topical SolutionPSN54885644-e51e-4263-aadb-366abaeb56a315
1367418thrombin alfa 1000 UNT in 1 ML Topical SolutionPSN54885644-e51e-4263-aadb-366abaeb56a315
1367420thrombin alfa 1000 UNT/ML Topical Solution [Recothrom]SBD54885644-e51e-4263-aadb-366abaeb56a315
1367418thrombin alfa 1000 UNT/ML Topical SolutionSCD54885644-e51e-4263-aadb-366abaeb56a315
1367418alfa-thrombin 1000 UNT/ML Topical SolutionSY54885644-e51e-4263-aadb-366abaeb56a315
1367420Recothrom 1000 UNT per 1 ML Topical SolutionSY54885644-e51e-4263-aadb-366abaeb56a315
1367420Recothrom 1000 UNT/ML (as alfa-thrombin) Topical SolutionSY54885644-e51e-4263-aadb-366abaeb56a315
1367420Recothrom 20,000 UNT per 20 ML Topical SolutionSY54885644-e51e-4263-aadb-366abaeb56a315
1367420Recothrom 5,000 UNT per 5 ML Topical SolutionSY54885644-e51e-4263-aadb-366abaeb56a315
1367418thrombin alfa 1000 UNT per 1 ML Topical SolutionSY54885644-e51e-4263-aadb-366abaeb56a315
1367418thrombin alfa 20,000 UNT per 20 ML Topical SolutionSY54885644-e51e-4263-aadb-366abaeb56a315

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0338-0328-010033803280120 mL in 1 VIAL20 mlHistorical
0338-0330-01003380330011 KIT in 1 KIT (0338-0330-01) * 20 mL in 1 VIAL (0338-0328-01) * 20 mL in 1 VIAL1 kit2008-06-090000-00-00NoNoCurrent