FDA.reportPublic FDA data

Insulin Diluting Medium for Garzulys

Product NDC
71288-909
Requested package NDC
71288-909-10
11-digit product format
712880909
Labeler code
71288
Product ID
71288-909_dbc6ea33-ff54-44b2-9ac7-cd76b4cb9c43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
water injection
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
BLA761497
Marketing category
BLA
Marketing start
2026-07-24
Substance
WATER
Active strength
1 mL/mL
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
Insulin Diluting Medium for Garzulys
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WATER1 mL/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
059QF0KO0RInternal UNII lookup
D933668QVXInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2748451Internal RxNorm lookup
2748457Internal RxNorm lookup
2748459Internal RxNorm lookup
2748463Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
30c64769-d2f7-4604-ac9e-2a6bc09506c9Available 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
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
application number: BLA761497
ndc (package): 71288-909-10
ndc (product): 71288-909
ndc11 (package): 71288090910

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761497Garzulysinsulin aspart-fsan351(k) InterchangeableRx2026-09-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71288-909-10712880909101 VIAL, GLASS in 1 CARTON (71288-909-10) / 10 mL in 1 VIAL, GLASS2026-07-24NoNoCurrent