Gazyva
- Product NDC
- 50242-070
- 11-digit product format
- 502420070
- Labeler code
- 50242
- Product ID
- 50242-070_47afa519-4a05-4ac2-8604-437371837128
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- obinutuzumab
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Genentech, Inc.
- Application
- BLA125486
- Marketing category
- BLA
- Marketing start
- 2013-11-01
- Substance
- OBINUTUZUMAB
- Active strength
- 1000 mg/40mL
- Pharmacologic classes
- CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Gazyva
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OBINUTUZUMAB | 1000 mg/40mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | O43472U9X8 |
| Rxcui | 1442693, 1442698 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50242-070-01 | Gazyva | 40 mL in 1 VIAL, SINGLE-USE | INJECTION, SOLUTION, CONCENTRATE | 40 | | 22 |
| 50242-070-01 | Gazyva | 1 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 1 | | 22 |
| 50242-070-86 | Gazyva | 40 mL in 1 VIAL, SINGLE-USE | INJECTION, SOLUTION, CONCENTRATE | 40 | | 22 |
| 50242-070-86 | Gazyva | 1 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 1 | | 22 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OBINUTUZUMAB | ACTIVE INGREDIENT | O43472U9X8 | GAZYVA (OBINUTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENENTECH, INC.] | 7 | |
| OBINUTUZUMAB | ACTIVE MOIETY | O43472U9X8 | GAZYVA (OBINUTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENENTECH, INC.] | 7 | |
| HISTIDINE | INACTIVE INGREDIENT | 4QD397987E | GAZYVA (OBINUTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENENTECH, INC.] | 7 | |
| HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE | INACTIVE INGREDIENT | X573657P6P | GAZYVA (OBINUTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENENTECH, INC.] | 7 | |
| POLOXAMER 188 | INACTIVE INGREDIENT | LQA7B6G8JG | GAZYVA (OBINUTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENENTECH, INC.] | 7 | |
| TREHALOSE DIHYDRATE | INACTIVE INGREDIENT | 7YIN7J07X4 | GAZYVA (OBINUTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENENTECH, INC.] | 7 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | GAZYVA (OBINUTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENENTECH, INC.] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50242-070 | GAZYVA (OBINUTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENENTECH, INC.] | 19 | Current NDC, Legacy NDC, 4 package rows | 20230825_df12ceb2-5b4b-4ab5-a317-2a36bf2a3cda.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 |
|---|
| 50242-070-01 | 50242007001 | 1 VIAL, SINGLE-USE in 1 CARTON (50242-070-01) / 40 mL in 1 VIAL, SINGLE-USE | 2013-11-01 | 0000-00-00 | No | No | Current |
| 50242-070-86 | 50242007086 | 1 VIAL, SINGLE-USE in 1 CARTON (50242-070-86) / 40 mL in 1 VIAL, SINGLE-USE | 2013-11-04 | 0000-00-00 | Yes | No | Current |