STEQEYMA
- Product NDC
- 72606-060
- 11-digit product format
- 726060060
- Labeler code
- 72606
- Product ID
- 72606-060_41fbe62e-a448-4c10-89fb-197959983091
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ustekinumab-stba
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- CELLTRION USA, Inc.
- Application
- BLA761338
- Marketing category
- BLA
- Marketing start
- 2026-04-13
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- STEQEYMA
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| USTEKINUMAB | 45 mg/.5mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | FU77B4U5Z0 |
| Rxcui | 2700393, 2700400, 2700404, 2700409, 2700411, 2700412, 2740798, 2740800 |
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 |
|---|---|---|---|---|---|---|
| 72606-060-01 | STEQEYMA | 0.5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 0.5 | 12 | |
| 72606-060-01 | STEQEYMA | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 12 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 72606-060-01 | ML - Milliliter | 72606-060 | b7e51155-6d38-4b5e-a202-672a5c1b8f82 | 1 | 2026-04-20 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2700400 | SteQeyma 130 MG in 26 ML Injection | PSN | 66085e17-e3f2-4196-8c81-87448e804b0c | 12 |
| 2740800 | SteQeyma 45 MG in 0.5 ML Injection | PSN | 66085e17-e3f2-4196-8c81-87448e804b0c | 12 |
| 2700409 | SteQeyma 45 MG in 0.5 ML Prefilled Syringe | PSN | 66085e17-e3f2-4196-8c81-87448e804b0c | 12 |
| 2700412 | SteQeyma 90 MG in 1 ML Prefilled Syringe | PSN | 66085e17-e3f2-4196-8c81-87448e804b0c | 12 |
| 2700393 | ustekinumab-stba 130 MG in 26 ML Injection | PSN | 66085e17-e3f2-4196-8c81-87448e804b0c | 12 |
| 2740798 | ustekinumab-stba 45 MG in 0.5 ML Injection | PSN | 66085e17-e3f2-4196-8c81-87448e804b0c | 12 |
| 2700404 | ustekinumab-stba 45 MG in 0.5 ML Prefilled Syringe | PSN | 66085e17-e3f2-4196-8c81-87448e804b0c | 12 |
| 2700411 | ustekinumab-stba 90 MG in 1 ML Prefilled Syringe | PSN | 66085e17-e3f2-4196-8c81-87448e804b0c | 12 |
| 2740800 | 0.5 ML ustekinumab-stba 90 MG/ML Injection [Steqeyma] | SBD | 66085e17-e3f2-4196-8c81-87448e804b0c | 12 |
| 2700409 | 0.5 ML ustekinumab-stba 90 MG/ML Prefilled Syringe [Steqeyma] | SBD | 66085e17-e3f2-4196-8c81-87448e804b0c | 12 |
| 2700412 | 1 ML ustekinumab-stba 90 MG/ML Prefilled Syringe [Steqeyma] | SBD | 66085e17-e3f2-4196-8c81-87448e804b0c | 12 |
| 2700400 | 26 ML ustekinumab-stba 5 MG/ML Injection [Steqeyma] | SBD | 66085e17-e3f2-4196-8c81-87448e804b0c | 12 |
| 2740798 | 0.5 ML ustekinumab-stba 90 MG/ML Injection | SCD | 66085e17-e3f2-4196-8c81-87448e804b0c | 12 |
| 2700404 | 0.5 ML ustekinumab-stba 90 MG/ML Prefilled Syringe | SCD | 66085e17-e3f2-4196-8c81-87448e804b0c | 12 |
| 2700411 | 1 ML ustekinumab-stba 90 MG/ML Prefilled Syringe | SCD | 66085e17-e3f2-4196-8c81-87448e804b0c | 12 |
| 2700393 | 26 ML ustekinumab-stba 5 MG/ML Injection | SCD | 66085e17-e3f2-4196-8c81-87448e804b0c | 12 |
| 2700400 | Steqeyma 130 MG per 26 ML Injection | SY | 66085e17-e3f2-4196-8c81-87448e804b0c | 12 |
| 2740800 | Steqeyma 45 MG per 0.5 ML Injection | SY | 66085e17-e3f2-4196-8c81-87448e804b0c | 12 |
| 2700409 | Steqeyma 45 MG per 0.5 ML Prefilled Syringe | SY | 66085e17-e3f2-4196-8c81-87448e804b0c | 12 |
| 2700400 | Steqeyma 5 MG/ML per 26 ML Injection | SY | 66085e17-e3f2-4196-8c81-87448e804b0c | 12 |
| 2700412 | Steqeyma 90 MG per 1 ML Prefilled Syringe | SY | 66085e17-e3f2-4196-8c81-87448e804b0c | 12 |
| 2700409 | Steqeyma 90 MG/ML per 0.5 ML Prefilled Syringe | SY | 66085e17-e3f2-4196-8c81-87448e804b0c | 12 |
| 2700412 | Steqeyma 90 MG/ML per 1 ML Prefilled Syringe | SY | 66085e17-e3f2-4196-8c81-87448e804b0c | 12 |
| 2700393 | ustekinumab-stba 130 MG per 26 ML Injection | SY | 66085e17-e3f2-4196-8c81-87448e804b0c | 12 |
| 2740798 | ustekinumab-stba 45 MG per 0.5 ML Injection | SY | 66085e17-e3f2-4196-8c81-87448e804b0c | 12 |
| 2700404 | ustekinumab-stba 45 MG per 0.5 ML Prefilled Syringe | SY | 66085e17-e3f2-4196-8c81-87448e804b0c | 12 |
| 2700393 | ustekinumab-stba 5 MG/ML per 26 ML Injection | SY | 66085e17-e3f2-4196-8c81-87448e804b0c | 12 |
| 2700411 | ustekinumab-stba 90 MG per 1 ML Prefilled Syringe | SY | 66085e17-e3f2-4196-8c81-87448e804b0c | 12 |
| 2700404 | ustekinumab-stba 90 MG/ML per 0.5 ML Prefilled Syringe | SY | 66085e17-e3f2-4196-8c81-87448e804b0c | 12 |
| 2700411 | ustekinumab-stba 90 MG/ML per 1 ML Prefilled Syringe | SY | 66085e17-e3f2-4196-8c81-87448e804b0c | 12 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 72606-060-01 | 72606006001 | 1 VIAL, SINGLE-DOSE in 1 CARTON (72606-060-01) / .5 mL in 1 VIAL, SINGLE-DOSE | 2026-04-13 | No | No | Current |