TZIELD
- Product NDC
- 73650-316
- 11-digit product format
- 736500316
- Labeler code
- 73650
- Product ID
- 73650-316_a43c4966-e649-4105-b439-eea5232c94f2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- teplizumab-mzwv
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Provention Bio, Inc.
- Application
- BLA761183
- Marketing category
- BLA
- Marketing start
- 2022-11-17
- Substance
- TEPLIZUMAB
- Active strength
- 1 mg/mL
- Pharmacologic classes
- CD3-directed Antibody Interactions [MoA], CD3-directed Antibody [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TZIELD
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TEPLIZUMAB | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | S4M959U2IJ |
| Rxcui | 2621885, 2621891 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 73650-316-01 | TZIELD | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 2 | | 6 |
| 73650-316-01 | TZIELD | 1 in 1 CARTON | INJECTION | 1 | | 6 |
| 73650-316-10 | TZIELD | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 2 | | 6 |
| 73650-316-10 | TZIELD | 10 in 1 CARTON | INJECTION | 10 | | 6 |
| 73650-316-14 | TZIELD | 14 in 1 CARTON | INJECTION | 14 | | 6 |
| 73650-316-14 | TZIELD | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 2 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 73650-316 | TZIELD (TEPLIZUMAB-MZWV) INJECTION [PROVENTION BIO, INC.] | 5 | Current NDC, Legacy NDC, 6 package rows | 20250508_e8a39a5f-139c-4510-9777-71cbb00138fa.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 |
|---|
| 73650-316-01 | 73650031601 | 1 VIAL, SINGLE-DOSE in 1 CARTON (73650-316-01) / 2 mL in 1 VIAL, SINGLE-DOSE | 2022-11-17 | 0000-00-00 | No | No | Current |
| 73650-316-10 | 73650031610 | 10 VIAL, SINGLE-DOSE in 1 CARTON (73650-316-10) > 2 mL in 1 VIAL, SINGLE-DOSE | 2022-11-17 | 0000-00-00 | No | No | Current |
| 73650-316-14 | 73650031614 | 14 VIAL, SINGLE-DOSE in 1 CARTON (73650-316-14) > 2 mL in 1 VIAL, SINGLE-DOSE | 2022-11-17 | 0000-00-00 | No | No | Current |