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KIRSTY

insulin aspart-xjhz · Injection, Solution

Prescription Biologic BLA

Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name

KIRSTY

Generic name

insulin aspart-xjhz

Dosage form

Injection, Solution

Route

Intravenous

Marketing category

BLA · BLA

Labeler

Biocon Biologics Inc.

Product type

Human Prescription Drug

DEA schedule

Not scheduled

Active ingredients

NDC product codes

Packages

Data completeness

52% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Insulin Aspart	100 [iU]/mL	1986354	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Injection, Solution

Route of administration

Intravenous

Presentations

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory

Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class	Type	Browse
Insulin Analog [EPC]	EPC	All 21 members
Insulin [CS]	CS	All 21 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

761188

Application type

BLA · Biologics License Application

Approval date

July 15, 2025

Sponsor

BIOCON BIOLOGICS INC

Products on application

Submissions recorded

Products approved under application 761188.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
761188-001	KIRSTY	INJECTION		INSULIN ASPART-XJHZ	Prescription	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 761188.
Type	No.	Action	Status	Date	Review
Original application	1	Type 5 - New Formulation or New Manufacturer	Approved	July 15, 2025	Standard

Review documents

0 · Original application · July 15, 2025
0 · Original application · July 15, 2025

Adverse event reports

Source: openFDA FAERS

65,753

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: INSULIN ASPART. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
83257-007-11	83257-007	Biocon Biologics Inc.	1 VIAL, MULTI-DOSE in 1 CARTON (83257-007-11) / 10 mL in 1 VIAL, MULTI-DOSE	September 15, 2025
83257-008-32	83257-008	Biocon Biologics Inc.	5 SYRINGE in 1 CARTON (83257-008-32) / 3 mL in 1 SYRINGE (83257-008-31)	September 15, 2025
83257-007	83257-007	Biocon Biologics Inc.	—	September 15, 2025
83257-008	83257-008	Biocon Biologics Inc.	—	September 15, 2025

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
FAERS	FDA	Adverse event report counts
Purple Book	FDA	Biologic licence classification

Generated September 25, 2026 · 9 sections on this page.