TRODELVY
- Product NDC
- 55135-132
- 11-digit product format
- 551350132
- Labeler code
- 55135
- Product ID
- 55135-132_18d71575-4896-4cfe-a9e8-a90fbd8bdb8a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SACITUZUMAB GOVITECAN
- Dosage form
- POWDER, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Gilead Sciences, Inc.
- Application
- BLA761115
- Marketing category
- BLA
- Marketing start
- 2020-04-22
- Substance
- SACITUZUMAB GOVITECAN
- Active strength
- 180 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TRODELVY
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SACITUZUMAB GOVITECAN | 180 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | M9BYU8XDQ6 |
| Rxcui | 2360534, 2360539 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55135-132-01 | TRODELVY | 1 in 1 BOX | POWDER, FOR SOLUTION | 1 | | 18 |
| 55135-132-01 | TRODELVY | 1 in 1 VIAL | POWDER, FOR SOLUTION | 1 | | 18 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55135-132 | TRODELVY (SACITUZUMAB GOVITECAN) POWDER, FOR SOLUTION [GILEAD SCIENCES, INC.] | 17 | Current NDC, Legacy NDC, 2 package rows | 20250406_57a597d2-03f0-472e-b148-016d7169169d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55135-132-01 | 55135013201 | 1 VIAL in 1 BOX (55135-132-01) / 1 POWDER, FOR SOLUTION in 1 VIAL | 1 vial | 2020-04-23 | 0000-00-00 | No | No | Current |