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
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| INSULIN ASPART | 100 [iU]/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | D933668QVX, 059QF0KO0R |
| Rxcui | 2720523, 2720529, 2720539, 2720541 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 24eab60a-55c8-40c1-8c86-7ed01a7a8bef | Product name | 1 | 20240227 |
| 09fb02dd-baf0-4f67-b464-599bf26324b6 | Product name | 2 | 20200323 |
| 6a6ef80c-37d6-4e02-aa78-fce7b811234e | Product name | 2 | 20200323 |
| 91ae268d-ee0f-6988-629d-5065a4376a50 | Product name | 2 | 20200323 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83257-007-11 | KIRSTY | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 10 | 4 | |
| 83257-007-11 | KIRSTY | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 83257-007-11 | ML - Milliliter | 83257-007 | d394b682-68e9-4b2e-84fa-000d314ebf29 | 1 | 2025-08-11 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2720539 | insulin aspart-xjhz 100 UNT/ML in 3 ML Pen Injector | PSN | 3db1d482-7e1f-aec6-79ef-3f305b4d8277 | 4 |
| 2720523 | insulin aspart-xjhz 100 UNT/ML Injectable Solution | PSN | 3db1d482-7e1f-aec6-79ef-3f305b4d8277 | 4 |
| 2720541 | Kirsty 100 UNT/ML in 3 ML Pen Injector | PSN | 3db1d482-7e1f-aec6-79ef-3f305b4d8277 | 4 |
| 2720529 | Kirsty 100 UNT/ML Injectable Solution | PSN | 3db1d482-7e1f-aec6-79ef-3f305b4d8277 | 4 |
| 2720541 | 3 ML insulin aspart-xjhz 100 UNT/ML Pen Injector [Kirsty] | SBD | 3db1d482-7e1f-aec6-79ef-3f305b4d8277 | 4 |
| 2720529 | insulin aspart-xjhz 100 UNT/ML Injectable Solution [Kirsty] | SBD | 3db1d482-7e1f-aec6-79ef-3f305b4d8277 | 4 |
| 2720539 | 3 ML insulin aspart-xjhz 100 UNT/ML Pen Injector | SCD | 3db1d482-7e1f-aec6-79ef-3f305b4d8277 | 4 |
| 2720523 | insulin aspart-xjhz 100 UNT/ML Injectable Solution | SCD | 3db1d482-7e1f-aec6-79ef-3f305b4d8277 | 4 |
| 2720539 | insulin aspart-xjhz 100 UNT/ML per 3 ML Pen Injector | SY | 3db1d482-7e1f-aec6-79ef-3f305b4d8277 | 4 |
| 2720529 | Kirsty 100 UNT/ML Injectable Solution | SY | 3db1d482-7e1f-aec6-79ef-3f305b4d8277 | 4 |
| 2720541 | Kirsty 100 UNT/ML per 3 ML Pen Injector | SY | 3db1d482-7e1f-aec6-79ef-3f305b4d8277 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 83257-007-11 | 83257000711 | 1 VIAL, MULTI-DOSE in 1 CARTON (83257-007-11) / 10 mL in 1 VIAL, MULTI-DOSE | 2025-09-15 | No | No | Historical |