KEVZARA
- Product NDC
- 0024-5910
- 11-digit product format
- 000245910
- Labeler code
- 0024
- Product ID
- 0024-5910_b1eeca31-be2b-4c68-a7c0-220256a2b906
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sarilumab
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Sanofi-Aventis U.S. LLC
- Application
- BLA761037
- Marketing category
- BLA
- Marketing start
- 2017-05-22
- Substance
- SARILUMAB
- Active strength
- 200 mg/1.14mL
- Pharmacologic classes
- Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- KEVZARA
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SARILUMAB | 200 mg/1.14mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | NU90V55F8I |
| Rxcui | 1923333, 1923338, 1923345, 1923347, 2003755, 2003757, 2003766, 2003767 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 729dde70-00cc-4ad7-bfd2-1334695b7e99 | Product name | 1 | 20170719 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 1681bc73-b05f-12c3-1075-382ae39f449c | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0024-5910-00 | KEVZARA | 1.14 mL in 1 SYRINGE | INJECTION, SOLUTION | 1.14 | 15 | |
| 0024-5910-01 | KEVZARA | 2 in 1 PACKAGE | INJECTION, SOLUTION | 2 | 15 | |
| 0024-5910-02 | KEVZARA | 1.14 mL in 1 SYRINGE | INJECTION, SOLUTION | 1.14 | 15 | |
| 0024-5910-02 | KEVZARA | 2 in 1 PACKAGE | INJECTION, SOLUTION | 2 | 15 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0024-5910-01 | ML - Milliliter | 0024-5910 | 737a55f3-5097-4704-924c-ad7710f3e45e | 1 | 2017-06-15 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2003757 | KEVZARA 150 MG in 1.14 mL Auto-Injector | PSN | 827bc01c-d379-4266-a18c-c7f904b76af3 | 15 |
| 1923338 | KEVZARA 150 MG in 1.14 mL Prefilled Syringe | PSN | 827bc01c-d379-4266-a18c-c7f904b76af3 | 15 |
| 2003767 | KEVZARA 200 MG in 1.14 mL Auto-Injector | PSN | 827bc01c-d379-4266-a18c-c7f904b76af3 | 15 |
| 1923347 | KEVZARA 200 MG in 1.14 mL Prefilled Syringe | PSN | 827bc01c-d379-4266-a18c-c7f904b76af3 | 15 |
| 2003755 | sarilumab 150 MG in 1.14 ML Auto-Injector | PSN | 827bc01c-d379-4266-a18c-c7f904b76af3 | 15 |
| 1923333 | sarilumab 150 MG in 1.14 mL Prefilled Syringe | PSN | 827bc01c-d379-4266-a18c-c7f904b76af3 | 15 |
| 2003766 | sarilumab 200 MG in 1.14 mL Auto-Injector | PSN | 827bc01c-d379-4266-a18c-c7f904b76af3 | 15 |
| 1923345 | sarilumab 200 MG in 1.14 mL Prefilled Syringe | PSN | 827bc01c-d379-4266-a18c-c7f904b76af3 | 15 |
| 2003757 | 1.14 ML sarilumab 132 MG/ML Auto-Injector [Kevzara] | SBD | 827bc01c-d379-4266-a18c-c7f904b76af3 | 15 |
| 1923338 | 1.14 ML sarilumab 132 MG/ML Prefilled Syringe [Kevzara] | SBD | 827bc01c-d379-4266-a18c-c7f904b76af3 | 15 |
| 2003767 | 1.14 ML sarilumab 175 MG/ML Auto-Injector [Kevzara] | SBD | 827bc01c-d379-4266-a18c-c7f904b76af3 | 15 |
| 1923347 | 1.14 ML sarilumab 175 MG/ML Prefilled Syringe [Kevzara] | SBD | 827bc01c-d379-4266-a18c-c7f904b76af3 | 15 |
| 2003755 | 1.14 ML sarilumab 132 MG/ML Auto-Injector | SCD | 827bc01c-d379-4266-a18c-c7f904b76af3 | 15 |
| 1923333 | 1.14 ML sarilumab 132 MG/ML Prefilled Syringe | SCD | 827bc01c-d379-4266-a18c-c7f904b76af3 | 15 |
| 2003766 | 1.14 ML sarilumab 175 MG/ML Auto-Injector | SCD | 827bc01c-d379-4266-a18c-c7f904b76af3 | 15 |
| 1923345 | 1.14 ML sarilumab 175 MG/ML Prefilled Syringe | SCD | 827bc01c-d379-4266-a18c-c7f904b76af3 | 15 |
| 2003757 | 1.14 ML Kevzara 132 MG/ML Auto-Injector | SY | 827bc01c-d379-4266-a18c-c7f904b76af3 | 15 |
| 1923338 | 1.14 ML Kevzara 132 MG/ML Prefilled Syringe | SY | 827bc01c-d379-4266-a18c-c7f904b76af3 | 15 |
| 2003767 | 1.14 ML Kevzara 175 MG/ML Auto-Injector | SY | 827bc01c-d379-4266-a18c-c7f904b76af3 | 15 |
| 1923347 | 1.14 ML Kevzara 175 MG/ML Prefilled Syringe | SY | 827bc01c-d379-4266-a18c-c7f904b76af3 | 15 |
| 2003757 | Kevzara 150 MG per 1.14 ML Auto-Injector | SY | 827bc01c-d379-4266-a18c-c7f904b76af3 | 15 |
| 1923338 | Kevzara 150 MG per 1.14 ML Prefilled Syringe | SY | 827bc01c-d379-4266-a18c-c7f904b76af3 | 15 |
| 2003767 | Kevzara 200 MG per 1.14 ML Auto-Injector | SY | 827bc01c-d379-4266-a18c-c7f904b76af3 | 15 |
| 1923347 | Kevzara 200 MG per 1.14 ML Prefilled Syringe | SY | 827bc01c-d379-4266-a18c-c7f904b76af3 | 15 |
| 2003755 | sarilumab 150 MG per 1.14 ML Auto-Injector | SY | 827bc01c-d379-4266-a18c-c7f904b76af3 | 15 |
| 1923333 | sarilumab 150 MG per 1.14 ML Prefilled Syringe | SY | 827bc01c-d379-4266-a18c-c7f904b76af3 | 15 |
| 2003766 | sarilumab 200 MG in 1.14 mL Auto-Injector | SY | 827bc01c-d379-4266-a18c-c7f904b76af3 | 15 |
| 1923345 | sarilumab 200 MG per 1.14 ML Prefilled Syringe | SY | 827bc01c-d379-4266-a18c-c7f904b76af3 | 15 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0024-5910-00 | 00024591000 | 1.14 mL in 1 SYRINGE | 1.14 ml | Historical | ||||
| 0024-5910-01 | 00024591001 | 2 SYRINGE in 1 PACKAGE (0024-5910-01) / 1.14 mL in 1 SYRINGE (0024-5910-00) | 2 syringe | 2017-05-22 | 0000-00-00 | No | No | Current |
| 0024-5910-02 | 00024591002 | 2 SYRINGE in 1 PACKAGE (0024-5910-02) / 1.14 mL in 1 SYRINGE | 2 syringe | 2017-05-22 | 0000-00-00 | No | No | Current |