Tecentriq Hybreza
- Product NDC
- 50242-933
- 11-digit product format
- 502420933
- Labeler code
- 50242
- Product ID
- 50242-933_87c7ca7b-0b4e-456a-8338-80c9613edb36
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- atezolizumab and hyaluronidase-tqjs
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- Genentech, Inc.
- Application
- BLA761347
- Marketing category
- BLA
- Marketing start
- 2024-09-12
- Substance
- ATEZOLIZUMAB; HYALURONIDASE (HUMAN RECOMBINANT)
- Active strength
- 1875; 30000 mg/15mL; U/15mL
- Pharmacologic classes
- Antibodies [CS], Antibodies, Monoclonal [CS], Antibodies, Monoclonal, Humanized [CS], Endoglycosidase [EPC], Glycoside Hydrolases [CS], Programmed Death Receptor-1 Blocking Antibody [EPC], Programmed Death Receptor-1-directed Antibody Interactions [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tecentriq Hybreza
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ATEZOLIZUMAB | 1875 mg/15mL |
| HYALURONIDASE (HUMAN RECOMBINANT) | 30000 U/15mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 52CMI0WC3Y, 743QUY4VD8 |
| Rxcui | 2693892, 2693899 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50242-933-01 | Tecentriq Hybreza | 15 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 15 | | 7 |
| 50242-933-01 | Tecentriq Hybreza | 1 in 1 BOX | INJECTION | 1 | | 7 |
| 50242-933-86 | Tecentriq Hybreza | 15 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 15 | | 7 |
| 50242-933-86 | Tecentriq Hybreza | 1 in 1 BOX | INJECTION | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50242-933 | TECENTRIQ HYBREZA (ATEZOLIZUMAB AND HYALURONIDASE-TQJS) INJECTION [GENENTECH, INC.] | 1 | Current NDC, 4 package rows | 20240927_a617b089-ce66-464b-987b-b45d029b4d6f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50242-933-01 | 50242093301 | 1 VIAL, SINGLE-DOSE in 1 BOX (50242-933-01) / 15 mL in 1 VIAL, SINGLE-DOSE | 2024-09-12 | No | No | Current |
| 50242-933-86 | 50242093386 | 1 VIAL, SINGLE-DOSE in 1 BOX (50242-933-86) / 15 mL in 1 VIAL, SINGLE-DOSE | 2024-09-12 | Yes | No | Current |