FDA.reportPublic FDA data

KIRSTY

Product NDC
83257-007
11-digit product format
832570007
Labeler code
83257
Product ID
83257-007_63e6a5cc-95ac-c07f-3c00-de5fbb395890
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
insulin aspart-xjhz
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Biocon Biologics Inc.
Application
BLA761188
Marketing category
BLA
Marketing start
2025-09-15
Substance
INSULIN ASPART
Active strength
100 [iU]/mL
Pharmacologic classes
Insulin Analog [EPC], Insulin [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
KIRSTY
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INSULIN ASPART100 [iU]/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
2720523Internal RxNorm lookup
2720529Internal RxNorm lookup
2720539Internal RxNorm lookup
2720541Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3db1d482-7e1f-aec6-79ef-3f305b4d8277Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
24eab60a-55c8-40c1-8c86-7ed01a7a8befProduct name120240227
09fb02dd-baf0-4f67-b464-599bf26324b6Product name220200323
6a6ef80c-37d6-4e02-aa78-fce7b811234eProduct name220200323
91ae268d-ee0f-6988-629d-5065a4376a50Product name220200323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83257-007-11KIRSTY10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION104
83257-007-11KIRSTY1 in 1 CARTONINJECTION, SOLUTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83257-007-11ML - Milliliter83257-007d394b682-68e9-4b2e-84fa-000d314ebf2912025-08-11

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
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
application number: BLA761188
ndc (product): 83257-007

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761188Kirstyinsulin aspart-xjhz351(k) InterchangeableRx2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2720539insulin aspart-xjhz 100 UNT/ML in 3 ML Pen InjectorPSN3db1d482-7e1f-aec6-79ef-3f305b4d82774
2720523insulin aspart-xjhz 100 UNT/ML Injectable SolutionPSN3db1d482-7e1f-aec6-79ef-3f305b4d82774
2720541Kirsty 100 UNT/ML in 3 ML Pen InjectorPSN3db1d482-7e1f-aec6-79ef-3f305b4d82774
2720529Kirsty 100 UNT/ML Injectable SolutionPSN3db1d482-7e1f-aec6-79ef-3f305b4d82774
27205413 ML insulin aspart-xjhz 100 UNT/ML Pen Injector [Kirsty]SBD3db1d482-7e1f-aec6-79ef-3f305b4d82774
2720529insulin aspart-xjhz 100 UNT/ML Injectable Solution [Kirsty]SBD3db1d482-7e1f-aec6-79ef-3f305b4d82774
27205393 ML insulin aspart-xjhz 100 UNT/ML Pen InjectorSCD3db1d482-7e1f-aec6-79ef-3f305b4d82774
2720523insulin aspart-xjhz 100 UNT/ML Injectable SolutionSCD3db1d482-7e1f-aec6-79ef-3f305b4d82774
2720539insulin aspart-xjhz 100 UNT/ML per 3 ML Pen InjectorSY3db1d482-7e1f-aec6-79ef-3f305b4d82774
2720529Kirsty 100 UNT/ML Injectable SolutionSY3db1d482-7e1f-aec6-79ef-3f305b4d82774
2720541Kirsty 100 UNT/ML per 3 ML Pen InjectorSY3db1d482-7e1f-aec6-79ef-3f305b4d82774

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83257-007-11832570007111 VIAL, MULTI-DOSE in 1 CARTON (83257-007-11) / 10 mL in 1 VIAL, MULTI-DOSE2025-09-15NoNoCurrent