Olanzapine
- Product NDC
- 67046-0539
- 11-digit product format
- 670460539
- Labeler code
- 67046
- Product ID
- 67046-0539_51b659fb-82d7-be78-e063-6394a90a4d0f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olanzapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA076255
- Marketing category
- ANDA
- Marketing start
- 2026-05-13
- Substance
- OLANZAPINE
- Active strength
- 2.5 mg/1
- 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 | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | N7U69T4SZR |
| Rxcui | 200034 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67046-0539-3 | Olanzapine | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 67046-0539-3 | 67046053903 | 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-0539-3) | 2026-05-13 | No | No | Current |