AUKELSO
- Product NDC
- 83257-030
- 11-digit product format
- 832570030
- Labeler code
- 83257
- Product ID
- 83257-030_09c9ae75-505b-dcae-8765-3628a32e7828
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Denosumab-kyqq
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- Biocon Biologics Inc.
- Application
- BLA761436
- Marketing category
- BLA
- Marketing start
- 2026-01-05
- Substance
- DENOSUMAB
- Active strength
- 120 mg/1.7mL
- Pharmacologic classes
- RANK Ligand Blocking Activity [MoA], RANK Ligand Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- AUKELSO
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DENOSUMAB | 120 mg/1.7mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 4EQZ6YO2HI |
| Rxcui | 2725939, 2725946 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6bd95106-a412-1dad-b9cc-4cb74bfb27ce | Product name | 2 | 20230315 |
| 48747306-602a-42cc-957b-5b0c69158eee | Product name | 1 | 20180604 |
| 31f7a69c-73ae-42bf-97ee-e31040596ed6 | Product name | 1 | 20180423 |
| b45e2e3f-1908-4144-8fa5-6f481dea7435 | Product name | 1 | 20170721 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 290f523a-f9db-9774-b5a9-e1f908ac1782 | Product name | 1 | 20150828 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| c6b65c52-69c7-df49-550a-a50c137f6218 | Product name | 1 | 20140508 |
| db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83257-030-11 | AUKELSO | 1.7 mL in 1 VIAL, SINGLE-USE | INJECTION | 1.7 | 2 | |
| 83257-030-11 | AUKELSO | 1 in 1 CARTON | INJECTION | 1 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 83257-030-11 | ML - Milliliter | 83257-030 | 2939f95b-f3dd-45e9-8f6f-d8ab85a6bde7 | 1 | 2026-03-17 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2725946 | Aukelso 120 MG in 1.7 ML Injection | PSN | 547cb095-f7f5-f933-75ce-5e6abf2ad5bc | 2 |
| 2725939 | denosumab-kyqq 120 MG in 1.7 ML Injection | PSN | 547cb095-f7f5-f933-75ce-5e6abf2ad5bc | 2 |
| 2725946 | 1.7 ML denosumab-kyqq 70 MG/ML Injection [Aukelso] | SBD | 547cb095-f7f5-f933-75ce-5e6abf2ad5bc | 2 |
| 2725939 | 1.7 ML denosumab-kyqq 70 MG/ML Injection | SCD | 547cb095-f7f5-f933-75ce-5e6abf2ad5bc | 2 |
| 2725946 | 1.7 ML Aukelso 70 MG/ML Injection | SY | 547cb095-f7f5-f933-75ce-5e6abf2ad5bc | 2 |
| 2725946 | Aukelso 120 MG per 1.7 ML Injection | SY | 547cb095-f7f5-f933-75ce-5e6abf2ad5bc | 2 |
| 2725939 | denosumab-kyqq 120 MG per 1.7 ML Injection | SY | 547cb095-f7f5-f933-75ce-5e6abf2ad5bc | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 83257-030-11 | 83257003011 | 1 VIAL, SINGLE-USE in 1 CARTON (83257-030-11) / 1.7 mL in 1 VIAL, SINGLE-USE | 2026-01-05 | No | No | Current |