TYENNE
- Product NDC
- 65219-586
- 11-digit product format
- 652190586
- Labeler code
- 65219
- Product ID
- 65219-586_90995548-9bf5-42ce-a93f-26b51a58044d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tocilizumab-aazg
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- BLA761275
- Marketing category
- BLA
- Marketing start
- 2024-07-01
- 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 table| Ingredient | Strength |
|---|
| TOCILIZUMAB | 162 mg/.9mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | I031V2H011 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65219-586-04 | TYENNE | 0.9 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 0.9 | | 4 |
| 65219-586-04 | TYENNE | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65219-586 | TYENNE (TOCILIZUMAB-AAZG) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 2 | Current NDC, 2 package rows | 20250210_ad76441d-da59-47df-8d9d-2243005180f0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65219-586-04 | 65219058604 | 1 SYRINGE, GLASS in 1 CARTON (65219-586-04) / .9 mL in 1 SYRINGE, GLASS | 2024-07-01 | 2027-12-31 | No | No | Historical |