Ocrevus Zunovo
- Product NDC
- 50242-554
- Requested package NDC
- 50242-554-86
- 11-digit product format
- 502420554
- Labeler code
- 50242
- Product ID
- 50242-554_31e224c7-7f86-4fd4-8f6c-34a80a099ce4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ocrelizumab and hyaluronidase
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Genentech, Inc.
- Application
- BLA761371
- Marketing category
- BLA
- Marketing start
- 2024-09-13
- Substance
- OCRELIZUMAB; HYALURONIDASE (HUMAN RECOMBINANT)
- Active strength
- 920; 23000 mg/23mL; U/23mL
- Pharmacologic classes
- Antibodies, Monoclonal [CS], Antibodies, Monoclonal, Humanized [CS], CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC], Endoglycosidase [EPC], Glycoside Hydrolases [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ocrevus Zunovo
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OCRELIZUMAB | 920 mg/23mL |
| HYALURONIDASE (HUMAN RECOMBINANT) | 23000 U/23mL |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50242-554-01 | Ocrevus Zunovo | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 9 |
| 50242-554-01 | Ocrevus Zunovo | 23 mL in 1 VIAL, SINGLE-USE | INJECTION, SOLUTION | 23 | | 9 |
| 50242-554-86 | Ocrevus Zunovo | 23 mL in 1 VIAL, SINGLE-USE | INJECTION, SOLUTION | 23 | | 9 |
| 50242-554-86 | Ocrevus Zunovo | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50242-554 | OCREVUS ZUNOVO (OCRELIZUMAB AND HYALURONIDASE) INJECTION, SOLUTION [GENENTECH, INC.] | 5 | Current NDC, 4 package rows | 20241127_b216af61-99d0-42a3-afc2-b5bf86df1ec0.zip |
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761371 | Ocrevus Zunovo | ocrelizumab and hyaluronidase-ocsq | 351(a) | Rx | 2026-09-01 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50242-554-86 | 50242055486 | 1 VIAL, SINGLE-USE in 1 CARTON (50242-554-86) / 23 mL in 1 VIAL, SINGLE-USE | 2024-09-13 | Yes | No | Current |