Home NDC 61755-012 Pasatru
Product NDC 61755-012
11-digit product format 617550012
Labeler code 61755
Product ID 61755-012_aa61176b-8199-47b9-ae53-66c4041f5ff5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name garetosmab-grts
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Regeneron Pharmaceuticals, Inc.
Application BLA761508
Marketing category BLA
Marketing start 2026-08-19
Substance GARETOSMAB
Active strength 300 mg/5mL
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Pasatru
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GARETOSMAB 300 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination KR9ZSKO5QE Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761508 Pasatru garetosmab-grts 351(a) Rx 2026-08-01
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Status 61755-012-01 61755001201 1 VIAL, SINGLE-DOSE in 1 CARTON (61755-012-01) / 5 mL in 1 VIAL, SINGLE-DOSE (61755-012-00) 2026-08-19 0 Current