Olanzapine
- Product NDC
- 0904-6376
- 11-digit product format
- 009046376
- Labeler code
- 0904
- Product ID
- 0904-6376_efc47d5e-306c-464d-92a4-5156031202cf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olanzapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA076255
- Marketing category
- ANDA
- Marketing start
- 2012-04-23
- Substance
- OLANZAPINE
- Active strength
- 10 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | N7U69T4SZR |
| Rxcui | 312078, 314154 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-6376-61 | Olanzapine | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 13 |
| 0904-6376-61 | Olanzapine | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-6376 | OLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 12 | Current NDC, Legacy NDC, 2 package rows | 20241122_0ecbf540-572e-4ca4-b694-18ca1cd1c194.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0904-6376-61 | 00904637661 | 100 BLISTER PACK in 1 CARTON (0904-6376-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 100 blister pack | 2012-04-23 | 0000-00-00 | No | No | Current |