Olanzapine
- Product NDC
- 67046-1550
- 11-digit product format
- 670461550
- Labeler code
- 67046
- Product ID
- 67046-1550_325d7012-77bd-83af-e063-6294a90a52ef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olanzapine
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA091265
- Marketing category
- ANDA
- Marketing start
- 2025-04-09
- Substance
- OLANZAPINE
- Active strength
- 5 mg/1
- 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
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OLANZAPINE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | N7U69T4SZR |
| Rxcui | 314155 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67046-1550-3 | Olanzapine | 30 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67046-1550 | OLANZAPINE TABLET, ORALLY DISINTEGRATING [COUPLER LLC] | 1 | Current NDC, 1 package rows | 20250410_325d5d69-5133-79ea-e063-6294a90afdd0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 67046-1550-3 | 67046155003 | 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (67046-1550-3) | 2025-04-09 | No | No | Historical |