Olanzapine
- Product NDC
- 65862-564
- 11-digit product format
- 658620564
- Labeler code
- 65862
- Product ID
- 65862-564_e10b90de-4a0a-413e-a5f9-6978a183b568
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olanzapine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA202050
- 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
- 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/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | N7U69T4SZR |
| Rxcui | 200034, 283639, 312077, 312078, 312079, 314154 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-564 | OLANZAPINE TABLET [AUROBINDO PHARMA LIMITED] | 20 | Current NDC, Legacy NDC, 5 package rows | 20250306_636665be-9d7e-443a-8134-e8cc47e6ba24.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 |
|---|
| 65862-564-01 | 65862056401 | 100 TABLET in 1 BOTTLE (65862-564-01) | 100 tablet | 2012-04-23 | 0000-00-00 | No | No | Current |
| 65862-564-10 | 65862056410 | 10 BLISTER PACK in 1 CARTON (65862-564-10) / 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2012-04-23 | 0000-00-00 | No | No | Current |
| 65862-564-30 | 65862056430 | 30 TABLET in 1 BOTTLE (65862-564-30) | 30 tablet | 2012-04-23 | 0000-00-00 | No | No | Current |
| 65862-564-99 | 65862056499 | 1000 TABLET in 1 BOTTLE (65862-564-99) | 1000 tablet | 2012-04-23 | 0000-00-00 | No | No | Current |