Olanzapine
- Product NDC
- 0143-9199
- 11-digit product format
- 001439199
- Labeler code
- 0143
- Product ID
- 0143-9199_0143693c-5d42-4674-9b76-06e8e9e0ed63
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olanzapine
- Dosage form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA218116
- Marketing category
- ANDA
- Marketing start
- 2025-09-18
- Substance
- OLANZAPINE
- Active strength
- 10 mg/2mL
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Olanzapine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OLANZAPINE | 10 mg/2mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | N7U69T4SZR |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0143-9199-01 | Olanzapine | 2 mL in 1 VIAL | INJECTION, POWDER, FOR SOLUTION | 2 | | 2 |
| 0143-9199-01 | Olanzapine | 1 in 1 CARTON | INJECTION, POWDER, FOR SOLUTION | 1 | | 2 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0143-9199-01 | 00143919901 | 1 VIAL in 1 CARTON (0143-9199-01) / 2 mL in 1 VIAL | 1 vial | 2025-09-18 | No | No | Historical |