Ontruzant
- Product NDC
- 78206-148
- 11-digit product format
- 782060148
- Labeler code
- 78206
- Product ID
- 78206-148_9b665849-a59e-4da6-ae51-36b3c885b85b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ontruzant
- Dosage form
- KIT
- Route
- INTRAVENOUS
- Labeler
- Organon LLC
- Application
- BLA761100
- Marketing category
- BLA
- Marketing start
- 2021-06-01
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ontruzant
- Listing expiration
- 2027-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | P188ANX8CK |
| Rxcui | 2289227, 2289232, 2289234, 2289237 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 78206-148-01 | Ontruzant | 1 in 1 CARTON | KIT | 1 | | 6 |
| 78206-191-99 | Ontruzant | 1 in 1 VIAL, MULTI-DOSE | INJECTION, POWDER, LYOPHILIZED, | 1 | 420 mg | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 78206-148 | ONTRUZANT (TRASTUZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION ONTRUZANT KIT [ORGANON LLC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20250316_ce2a2492-85e3-4b0a-872a-047f44e4203d.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 |
|---|
| 78206-148-01 | 78206014801 | 1 KIT in 1 CARTON (78206-148-01) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, MULTI-DOSE (78206-191-99) * 1 INJECTION, SOLUTION in 1 VIAL (78206-149-89) | 1 kit | 2021-06-01 | 0000-00-00 | No | No | Current |
| 78206-191-99 | 78206019199 | 1 in 1 VIAL, MULTI-DOSE | | | | | | Historical |