Olanzapine
- Product NDC
- 0832-6081
- 11-digit product format
- 008326081
- Labeler code
- 0832
- Product ID
- 0832-6081_8360dfb0-5f3a-4b86-8b46-fc89c12aad6b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olanzapine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Upsher-Smith Laboratories, LLC
- Application
- ANDA204319
- Marketing category
- ANDA
- Marketing start
- 2016-01-27
- Marketing end
- 2026-08-31
- Substance
- OLANZAPINE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Olanzapine
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OLANZAPINE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | N7U69T4SZR |
| Rxcui | 200034, 283639, 312077, 312078, 312079, 314154 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0832-6081-03 | Olanzapine | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
| 0832-6081-50 | Olanzapine | 500 in 1 BOTTLE | TABLET | 500 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0832-6081 | OLANZAPINE TABLET [UPSHER-SMITH LABORATORIES, LLC] | 1 | Current NDC, 2 package rows | 20240807_dbe23f33-9e7d-49a7-8528-fa290661a96f.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 |
|---|
| 0832-6081-03 | 00832608103 | 30 TABLET in 1 BOTTLE (0832-6081-03) | 30 tablet | 2024-08-15 | 2026-08-31 | No | No | Historical |
| 0832-6081-50 | 00832608150 | 500 TABLET in 1 BOTTLE (0832-6081-50) | 500 tablet | 2024-08-15 | 2026-08-31 | No | No | Historical |