Ontruzant
- Product NDC
- 0006-5033
- 11-digit product format
- 000065033
- Labeler code
- 0006
- Product ID
- 0006-5033_419c4f97-e6d6-4bed-9014-a69a39d2149f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- trastuzumab
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Merck Sharp & Dohme Corp.
- Application
- BLA761100
- Marketing category
- BLA
- Marketing start
- 2020-04-15
- Marketing end
- 2023-09-30
- Substance
- TRASTUZUMAB
- Active strength
- 150 mg/1
- Pharmacologic classes
- HER2/neu Receptor Antagonist [EPC],HER2/Neu/cerbB2 Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0006-5033-02 | 00006503302 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0006-5033-02) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0006-5033-01) | 2020-04-15 | 0000-00-00 | No | No | Current |