Starjemza
- Product NDC
- 0143-9169
- 11-digit product format
- 001439169
- Labeler code
- 0143
- Product ID
- 0143-9169_4f0ed512-9cd1-4280-af36-37ed3090d632
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ustekinumab-hmny
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- BLA761419
- Marketing category
- BLA
- Marketing start
- 2025-10-27
- Substance
- USTEKINUMAB
- Active strength
- 45 mg/.5mL
- Pharmacologic classes
- Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Starjemza
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| USTEKINUMAB | 45 mg/.5mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | FU77B4U5Z0 |
| Rxcui | 2725087, 2725094, 2725099, 2725100, 2725102, 2725106, 2725111, 2725114 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 9101c6a6-2dd0-4586-9db6-ccb20dc679c9 | Product name | 2 | 20171206 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0143-9169-01 | Starjemza | 0.5 mL in 1 VIAL | INJECTION | 0.5 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0143-9169-01 | ML - Milliliter | 0143-9169 | b43a438d-c539-4197-ab19-349167f69356 | 1 | 2025-11-13 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2725114 | Starjemza 130 MG in 26 ML Injection | PSN | 8b72aa27-82cc-4c1b-be43-8b50e5e3d737 | 5 |
| 2725106 | Starjemza 45 MG in 0.5 ML Injection | PSN | 8b72aa27-82cc-4c1b-be43-8b50e5e3d737 | 5 |
| 2725094 | Starjemza 45 MG in 0.5 ML Prefilled Syringe | PSN | 8b72aa27-82cc-4c1b-be43-8b50e5e3d737 | 5 |
| 2725100 | Starjemza 90 MG in 1 ML Prefilled Syringe | PSN | 8b72aa27-82cc-4c1b-be43-8b50e5e3d737 | 5 |
| 2725111 | ustekinumab-hmny 130 MG in 26 ML Injection | PSN | 8b72aa27-82cc-4c1b-be43-8b50e5e3d737 | 5 |
| 2725102 | ustekinumab-hmny 45 MG in 0.5 ML Injection | PSN | 8b72aa27-82cc-4c1b-be43-8b50e5e3d737 | 5 |
| 2725087 | ustekinumab-hmny 45 MG in 0.5 ML Prefilled Syringe | PSN | 8b72aa27-82cc-4c1b-be43-8b50e5e3d737 | 5 |
| 2725099 | ustekinumab-hmny 90 MG in 1 ML Prefilled Syringe | PSN | 8b72aa27-82cc-4c1b-be43-8b50e5e3d737 | 5 |
| 2725106 | 0.5 ML ustekinumab-hmny 90 MG/ML Injection [Starjemza] | SBD | 8b72aa27-82cc-4c1b-be43-8b50e5e3d737 | 5 |
| 2725094 | 0.5 ML ustekinumab-hmny 90 MG/ML Prefilled Syringe [Starjemza] | SBD | 8b72aa27-82cc-4c1b-be43-8b50e5e3d737 | 5 |
| 2725100 | 1 ML ustekinumab-hmny 90 MG/ML Prefilled Syringe [Starjemza] | SBD | 8b72aa27-82cc-4c1b-be43-8b50e5e3d737 | 5 |
| 2725114 | 26 ML ustekinumab-hmny 5 MG/ML Injection [Starjemza] | SBD | 8b72aa27-82cc-4c1b-be43-8b50e5e3d737 | 5 |
| 2725102 | 0.5 ML ustekinumab-hmny 90 MG/ML Injection | SCD | 8b72aa27-82cc-4c1b-be43-8b50e5e3d737 | 5 |
| 2725087 | 0.5 ML ustekinumab-hmny 90 MG/ML Prefilled Syringe | SCD | 8b72aa27-82cc-4c1b-be43-8b50e5e3d737 | 5 |
| 2725099 | 1 ML ustekinumab-hmny 90 MG/ML Prefilled Syringe | SCD | 8b72aa27-82cc-4c1b-be43-8b50e5e3d737 | 5 |
| 2725111 | 26 ML ustekinumab-hmny 5 MG/ML Injection | SCD | 8b72aa27-82cc-4c1b-be43-8b50e5e3d737 | 5 |
| 2725114 | Starjemza 130 MG per 26 ML Injection | SY | 8b72aa27-82cc-4c1b-be43-8b50e5e3d737 | 5 |
| 2725106 | Starjemza 45 MG per 0.5 ML Injection | SY | 8b72aa27-82cc-4c1b-be43-8b50e5e3d737 | 5 |
| 2725094 | Starjemza 45 MG per 0.5 ML Prefilled Syringe | SY | 8b72aa27-82cc-4c1b-be43-8b50e5e3d737 | 5 |
| 2725100 | Starjemza 90 MG per 1 ML Prefilled Syringe | SY | 8b72aa27-82cc-4c1b-be43-8b50e5e3d737 | 5 |
| 2725111 | ustekinumab-hmny 130 MG per 26 ML Injection | SY | 8b72aa27-82cc-4c1b-be43-8b50e5e3d737 | 5 |
| 2725102 | ustekinumab-hmny 45 MG per 0.5 ML Injection | SY | 8b72aa27-82cc-4c1b-be43-8b50e5e3d737 | 5 |
| 2725087 | ustekinumab-hmny 45 MG per 0.5 ML Prefilled Syringe | SY | 8b72aa27-82cc-4c1b-be43-8b50e5e3d737 | 5 |
| 2725099 | ustekinumab-hmny 90 MG per 1 ML Prefilled Syringe | SY | 8b72aa27-82cc-4c1b-be43-8b50e5e3d737 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 0143-9169-01 | 00143916901 | .5 mL in 1 VIAL (0143-9169-01) | 2025-10-27 | No | No | Current |