OLANZAPINE
- Product NDC
- 83854-003
- 11-digit product format
- 838540003
- Labeler code
- 83854
- Product ID
- 83854-003_4c557545-1a58-5183-e063-6394a90a1028
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OLANZAPINE
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- Anthea Pharma Private Limited
- Application
- ANDA220323
- Marketing category
- ANDA
- Marketing start
- 2026-03-05
- 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 |
|---|
| 83854-003-01 | OLANZAPINE | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 4 |
| 83854-003-01 | OLANZAPINE | 2 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 2 | | 4 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 83854-003-01 | 83854000301 | 1 VIAL in 1 CARTON (83854-003-01) / 2 mL in 1 VIAL | 1 vial | 2026-03-05 | No | No | Current |