Olanzapine
- Product NDC
- 39822-1800
- 11-digit product format
- 398221800
- Labeler code
- 39822
- Product ID
- 39822-1800_4e3e841b-77b2-d902-e063-6294a90a9842
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olanzapine
- Dosage form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- XGen Pharmaceuticals DJB, Inc.
- Application
- ANDA211072
- Marketing category
- ANDA
- Marketing start
- 2025-08-28
- Substance
- OLANZAPINE
- Active strength
- 10 mg/2mL
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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 |
| Rxcui | 485968 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 39822-1800-1 | Olanzapine | 2 mL in 1 VIAL | INJECTION, POWDER, FOR SOLUTION | 2 | | 2 |
| 39822-1800-1 | Olanzapine | 1 in 1 CARTON | INJECTION, POWDER, FOR SOLUTION | 1 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 39822-1800-1 | 39822180001 | 1 VIAL in 1 CARTON (39822-1800-1) / 2 mL in 1 VIAL | 1 vial | 2025-09-02 | No | No | Current |