FDA.reportPublic FDA data

RECOTHROM

Product NDC
0338-0322
11-digit product format
003380322
Labeler code
0338
Product ID
0338-0322_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
2008-01-29
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
ndc (product): 0338-0322

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
0338-0322-01RECOTHROM1 in 1 KITKIT115
0338-0324-01RECOTHROM5 mL in 1 VIALPOWDER, FOR SOLUTION5 mL1000 [iU] in 1mL15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-0322-01EA - Each0338-0322b90b86e3-6c45-4a7f-bb60-2a65a30588f312019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-0322RECOTHROM (THROMBIN TOPICAL RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]12Current NDC, Legacy NDC, 2 package rows20240119_54885644-e51e-4263-aadb-366abaeb56a3.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 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
0338-0322-01003380322011 KIT in 1 KIT (0338-0322-01) * 5 mL in 1 VIAL (0338-0324-01) * 5 mL in 1 SYRINGE1 kit2008-01-290000-00-00NoNoCurrent
0338-0324-01003380324015 mL in 1 VIAL5 mlHistorical