Home NDC 0338-0322 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 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 Identifier FDA.report destination 1367418 Internal RxNorm lookup 1367420 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0338-0322-01 RECOTHROM 1 in 1 KIT KIT 1 15 0338-0324-01 RECOTHROM 5 mL in 1 VIAL POWDER, FOR SOLUTION 5 mL 1000 [iU] in 1mL 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0338-0322 RECOTHROM (THROMBIN TOPICAL RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION] 12 Current NDC, Legacy NDC, 2 package rows 20240119_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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join RECOTHROM THROMBIN TOPICAL RECOMBINANT Baxter Healthcare Corporation 54885644-e51e-4263-aadb-366abaeb56a3 2025-06-09 Warnings, Adverse reactions Exact identifier application number: BLA125248 ndc (product): 0338-0322
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125248 Recothrom Thrombin topical (Recombinant) 351(a) Rx 2026-08-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0338-0322-01 00338032201 1 KIT in 1 KIT (0338-0322-01) * 5 mL in 1 VIAL (0338-0324-01) * 5 mL in 1 SYRINGE 1 kit 2008-01-29 0000-00-00 No No Current 0338-0324-01 00338032401 5 mL in 1 VIAL 5 ml Historical