FDA.reportPublic FDA data

Pasatru

Product NDC
61755-012
Requested package NDC
61755-012-01
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
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
Pasatru
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GARETOSMAB300 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
KR9ZSKO5QEInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2749959Internal RxNorm lookup
2749966Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0d5cec96-b02b-4f1d-bc66-51e62ce04e3cAvailable on FDA.report

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
PasatruGARETOSMAB-GRTSRegeneron Pharmaceuticals, Inc.0d5cec96-b02b-4f1d-bc66-51e62ce04e3c2026-08-14Warnings, Adverse reactionsExact identifier
application number: BLA761508
ndc (package): 61755-012-01
ndc (product): 61755-012
ndc11 (package): 61755001201

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761508Pasatrugaretosmab-grts351(a)Rx2026-09-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
61755-012-01617550012011 VIAL, SINGLE-DOSE in 1 CARTON (61755-012-01) / 5 mL in 1 VIAL, SINGLE-DOSE (61755-012-00) 2026-08-19NoNoCurrent