TYENNE
- Product NDC
- 65219-598
- 11-digit product format
- 652190598
- Labeler code
- 65219
- Product ID
- 65219-598_87ac5047-4f2b-4571-a8a8-32e08865f379
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tocilizumab-aazg
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- BLA761449
- Marketing category
- BLA
- Marketing start
- 2025-09-01
- Substance
- TOCILIZUMAB
- Active strength
- 162 mg/.9mL
- Pharmacologic classes
- Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TYENNE
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TOCILIZUMAB | 162 mg/.9mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | I031V2H011 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 9f5f0f3b-b458-45da-a406-00e2782d440a | Product name | 1 | 20150818 |
| 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 |
|---|---|---|---|---|---|---|
| 65219-598-10 | TYENNE | 0.9 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 0.9 | 1 | |
| 65219-598-10 | TYENNE | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65219-598-10 | ML - Milliliter | 65219-598 | 935045fc-02e6-40ee-864c-6afb8501f03d | 1 | 2025-10-14 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2686045 | tocilizumab-aazg 162 MG in 0.9 ML Auto-Injector | PSN | 87ac5047-4f2b-4571-a8a8-32e08865f379 | 1 |
| 2686053 | tocilizumab-aazg 162 MG in 0.9 ML Prefilled Syringe | PSN | 87ac5047-4f2b-4571-a8a8-32e08865f379 | 1 |
| 2686050 | Tyenne 162 MG in 0.9 ML Auto-Injector | PSN | 87ac5047-4f2b-4571-a8a8-32e08865f379 | 1 |
| 2686057 | Tyenne 162 MG in 0.9 ML Prefilled Syringe | PSN | 87ac5047-4f2b-4571-a8a8-32e08865f379 | 1 |
| 2686050 | 0.9 ML tocilizumab-aazg 180 MG/ML Auto-Injector [Tyenne] | SBD | 87ac5047-4f2b-4571-a8a8-32e08865f379 | 1 |
| 2686057 | 0.9 ML tocilizumab-aazg 180 MG/ML Prefilled Syringe [Tyenne] | SBD | 87ac5047-4f2b-4571-a8a8-32e08865f379 | 1 |
| 2686045 | 0.9 ML tocilizumab-aazg 180 MG/ML Auto-Injector | SCD | 87ac5047-4f2b-4571-a8a8-32e08865f379 | 1 |
| 2686053 | 0.9 ML tocilizumab-aazg 180 MG/ML Prefilled Syringe | SCD | 87ac5047-4f2b-4571-a8a8-32e08865f379 | 1 |
| 2686045 | tocilizumab-aazg 162 MG per 0.9 ML Auto-Injector | SY | 87ac5047-4f2b-4571-a8a8-32e08865f379 | 1 |
| 2686053 | tocilizumab-aazg 162 MG per 0.9 ML Prefilled Syringe | SY | 87ac5047-4f2b-4571-a8a8-32e08865f379 | 1 |
| 2686050 | Tyenne 162 MG per 0.9 ML Auto-Injector | SY | 87ac5047-4f2b-4571-a8a8-32e08865f379 | 1 |
| 2686057 | Tyenne 162 MG per 0.9 ML Prefilled Syringe | SY | 87ac5047-4f2b-4571-a8a8-32e08865f379 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 65219-598-10 | 65219059810 | 1 SYRINGE, GLASS in 1 CARTON (65219-598-10) / .9 mL in 1 SYRINGE, GLASS | 2025-09-01 | No | No | Current |