WELTRUZA
- Product NDC
- 51759-349
- 11-digit product format
- 517590349
- Labeler code
- 51759
- Product ID
- 51759-349_1c998762-8d30-4afd-b0d5-282bcaaefb8d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- olanzapine
- Dosage form
- KIT
- Route
- SUBCUTANEOUS
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- NDA219007
- Marketing category
- NDA
- Marketing start
- 2026-11-02
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Source provenance: Browse the complete Orange Book source catalog.
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
- WELTRUZA
- Listing expiration
- 2027-12-31
Harmonized SPL set identifiers#
SPL set identifiers page 1 of 1 · 1 matching rows.
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 51759-349-50 | 51759034950 | 1 KIT in 1 CARTON (51759-349-50) * 1.5 mL in 1 VIAL (51759-355-50) * 1.5 mL in 1 SYRINGE (51759-358-10) | 1 kit | 2026-11-02 | No | No | Current |