COSENTYX
- Product NDC
- 0078-1070
- 11-digit product format
- 000781070
- Labeler code
- 0078
- Product ID
- 0078-1070_ecc0059c-d566-4830-b4c1-35535c9ecca2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- secukinumab
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- Novartis Pharmaceuticals Corporation
- Application
- BLA125504
- Marketing category
- BLA
- Marketing start
- 2015-01-21
- Substance
- SECUKINUMAB
- Active strength
- 300 mg/2mL
- Pharmacologic classes
- Interleukin-17A Antagonist [EPC], Interleukin-17A 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
- COSENTYX
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SECUKINUMAB | 300 mg/2mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | DLG4EML025 |
| Rxcui | 1599792, 1599797, 1653241, 1653243, 2550712, 2550713, 2637347, 2637348, 2667419, 2667423 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 27e332fb-2926-4a3d-abaa-4cdc3ec3b214 | Product name | 3 | 20250627 |
| 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 |
|---|---|---|---|---|---|---|
| 0078-1070-68 | COSENTYX | 1 in 1 CARTON | INJECTION | 1 | 29 | |
| 0078-1070-68 | COSENTYX | 2 mL in 1 SYRINGE, GLASS | INJECTION | 2 | 29 | |
| 0078-1070-96 | COSENTYX | 1 in 1 CARTON | INJECTION | 1 | 29 | |
| 0078-1070-96 | COSENTYX | 2 mL in 1 SYRINGE, GLASS | INJECTION | 2 | 29 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0078-1070-68 | ML - Milliliter | 0078-1070 | 49276431-cb3f-42e1-817f-9947e17f30da | 1 | 2023-08-08 |
| 0078-1070-96 | ML - Milliliter | 0078-1070 | 2dd20609-1957-4901-b267-1f6908ada26c | 1 | 2025-01-14 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| SECUKINUMAB | ACTIVE INGREDIENT | DLG4EML025 | COSENTYX (SECUKINUMAB) INJECTION [NOVARTIS PHARMACEUTICALS CORPORATION] | 1 | |
| SECUKINUMAB | ACTIVE MOIETY | DLG4EML025 | COSENTYX (SECUKINUMAB) INJECTION [NOVARTIS PHARMACEUTICALS CORPORATION] | 1 | |
| HISTIDINE | INACTIVE INGREDIENT | 4QD397987E | COSENTYX (SECUKINUMAB) INJECTION [NOVARTIS PHARMACEUTICALS CORPORATION] | 1 | |
| HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE | INACTIVE INGREDIENT | X573657P6P | COSENTYX (SECUKINUMAB) INJECTION [NOVARTIS PHARMACEUTICALS CORPORATION] | 1 | |
| METHIONINE | INACTIVE INGREDIENT | AE28F7PNPL | COSENTYX (SECUKINUMAB) INJECTION [NOVARTIS PHARMACEUTICALS CORPORATION] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | COSENTYX (SECUKINUMAB) INJECTION [NOVARTIS PHARMACEUTICALS CORPORATION] | 1 | |
| TREHALOSE DIHYDRATE | INACTIVE INGREDIENT | 7YIN7J07X4 | COSENTYX (SECUKINUMAB) INJECTION [NOVARTIS PHARMACEUTICALS CORPORATION] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | COSENTYX (SECUKINUMAB) INJECTION [NOVARTIS PHARMACEUTICALS CORPORATION] | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0078-1070 | COSENTYX (SECUKINUMAB) INJECTION COSENTYX (SECUKINUMAB) INJECTION, SOLUTION, CONCENTRATE [NOVARTIS PHARMACEUTICALS CORPORATION] | 24 | Current NDC, 4 package rows | 20241013_77c4b13e-7df3-42d4-81db-3d0cddb7f67a.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2667423 | Cosentyx 125 MG in 5 ML Injection | PSN | 77c4b13e-7df3-42d4-81db-3d0cddb7f67a | 29 |
| 1653243 | Cosentyx 150 MG in 1 ML Auto-Injector | PSN | 77c4b13e-7df3-42d4-81db-3d0cddb7f67a | 29 |
| 1599797 | Cosentyx 150 MG in 1 ML Prefilled Syringe | PSN | 77c4b13e-7df3-42d4-81db-3d0cddb7f67a | 29 |
| 2637348 | Cosentyx 300 MG in 2 ML Auto-Injector | PSN | 77c4b13e-7df3-42d4-81db-3d0cddb7f67a | 29 |
| 2550713 | Cosentyx 75 MG in 0.5 ML Prefilled Syringe | PSN | 77c4b13e-7df3-42d4-81db-3d0cddb7f67a | 29 |
| 2667419 | secukinumab 125 MG in 5 ML Injection | PSN | 77c4b13e-7df3-42d4-81db-3d0cddb7f67a | 29 |
| 1653241 | secukinumab 150 MG in 1 ML Auto-Injector | PSN | 77c4b13e-7df3-42d4-81db-3d0cddb7f67a | 29 |
| 1599792 | secukinumab 150 MG in 1 ML Prefilled Syringe | PSN | 77c4b13e-7df3-42d4-81db-3d0cddb7f67a | 29 |
| 2637347 | secukinumab 300 MG in 2 ML Auto-Injector | PSN | 77c4b13e-7df3-42d4-81db-3d0cddb7f67a | 29 |
| 2550712 | secukinumab 75 MG in 0.5 ML Prefilled Syringe | PSN | 77c4b13e-7df3-42d4-81db-3d0cddb7f67a | 29 |
| 2550713 | 0.5 ML secukinumab 150 MG/ML Prefilled Syringe [Cosentyx] | SBD | 77c4b13e-7df3-42d4-81db-3d0cddb7f67a | 29 |
| 1653243 | 1 ML secukinumab 150 MG/ML Auto-Injector [Cosentyx] | SBD | 77c4b13e-7df3-42d4-81db-3d0cddb7f67a | 29 |
| 1599797 | 1 ML secukinumab 150 MG/ML Prefilled Syringe [Cosentyx] | SBD | 77c4b13e-7df3-42d4-81db-3d0cddb7f67a | 29 |
| 2637348 | 2 ML secukinumab 150 MG/ML Auto-Injector [Cosentyx] | SBD | 77c4b13e-7df3-42d4-81db-3d0cddb7f67a | 29 |
| 2667423 | 5 ML secukinumab 25 MG/ML Injection [Cosentyx] | SBD | 77c4b13e-7df3-42d4-81db-3d0cddb7f67a | 29 |
| 2550712 | 0.5 ML secukinumab 150 MG/ML Prefilled Syringe | SCD | 77c4b13e-7df3-42d4-81db-3d0cddb7f67a | 29 |
| 1653241 | 1 ML secukinumab 150 MG/ML Auto-Injector | SCD | 77c4b13e-7df3-42d4-81db-3d0cddb7f67a | 29 |
| 1599792 | 1 ML secukinumab 150 MG/ML Prefilled Syringe | SCD | 77c4b13e-7df3-42d4-81db-3d0cddb7f67a | 29 |
| 2637347 | 2 ML secukinumab 150 MG/ML Auto-Injector | SCD | 77c4b13e-7df3-42d4-81db-3d0cddb7f67a | 29 |
| 2667419 | 5 ML secukinumab 25 MG/ML Injection | SCD | 77c4b13e-7df3-42d4-81db-3d0cddb7f67a | 29 |
| 2550713 | 0.5 ML Cosentyx 150 MG/ML Prefilled Syringe | SY | 77c4b13e-7df3-42d4-81db-3d0cddb7f67a | 29 |
| 1653243 | 1 ML Cosentyx 150 MG/ML Auto-Injector | SY | 77c4b13e-7df3-42d4-81db-3d0cddb7f67a | 29 |
| 1599797 | 1 ML Cosentyx 150 MG/ML Prefilled Syringe | SY | 77c4b13e-7df3-42d4-81db-3d0cddb7f67a | 29 |
| 2637348 | 2 ML Cosentyx 150 MG/ML Auto-Injector | SY | 77c4b13e-7df3-42d4-81db-3d0cddb7f67a | 29 |
| 2667423 | 5 ML Cosentyx 25 MG/ML Injection | SY | 77c4b13e-7df3-42d4-81db-3d0cddb7f67a | 29 |
| 2667423 | Cosentyx 125 MG per 5 ML Injection | SY | 77c4b13e-7df3-42d4-81db-3d0cddb7f67a | 29 |
| 1653243 | Cosentyx 150 MG per 1 ML Auto-Injector | SY | 77c4b13e-7df3-42d4-81db-3d0cddb7f67a | 29 |
| 1599797 | Cosentyx 150 MG/ML 1ML Prefilled Syringe | SY | 77c4b13e-7df3-42d4-81db-3d0cddb7f67a | 29 |
| 2637348 | Cosentyx 300 MG per 2 ML Auto-Injector | SY | 77c4b13e-7df3-42d4-81db-3d0cddb7f67a | 29 |
| 2550713 | Cosentyx 75 MG per 0.5 ML Prefilled Syringe | SY | 77c4b13e-7df3-42d4-81db-3d0cddb7f67a | 29 |
| 2667419 | secukinumab 125 MG per 5 ML Injection | SY | 77c4b13e-7df3-42d4-81db-3d0cddb7f67a | 29 |
| 1653241 | secukinumab 150 MG per 1 ML Auto-Injector | SY | 77c4b13e-7df3-42d4-81db-3d0cddb7f67a | 29 |
| 1599792 | secukinumab 150 MG/ML 1ML Prefilled Syringe | SY | 77c4b13e-7df3-42d4-81db-3d0cddb7f67a | 29 |
| 2637347 | secukinumab 300 MG per 2 ML Auto-Injector | SY | 77c4b13e-7df3-42d4-81db-3d0cddb7f67a | 29 |
| 2550712 | secukinumab 75 MG per 0.5 ML Prefilled Syringe | SY | 77c4b13e-7df3-42d4-81db-3d0cddb7f67a | 29 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 0078-1070-68 | 00078107068 | 1 SYRINGE, GLASS in 1 CARTON (0078-1070-68) / 2 mL in 1 SYRINGE, GLASS | 2023-05-11 | No | No | Current |
| 0078-1070-96 | 00078107096 | 1 SYRINGE, GLASS in 1 CARTON (0078-1070-96) / 2 mL in 1 SYRINGE, GLASS | 2023-05-11 | Yes | No | Current |