Olanzapine
- Product NDC
- 65862-657
- 11-digit product format
- 658620657
- Labeler code
- 65862
- Product ID
- 65862-657_4f9fe058-fa71-4b85-9bad-482ade6b085e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olanzapine
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA203708
- Marketing category
- ANDA
- Marketing start
- 2014-05-15
- 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 | 312076, 314155, 351107, 351108 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65862-657-03 | Olanzapine | 03 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 03 | | 16 |
| 65862-657-10 | Olanzapine | 10 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 10 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-657 | OLANZAPINE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED] | 14 | Current NDC, Legacy NDC, 2 package rows | 20250312_4d768cfe-3b20-4127-95b9-b4151b28afcc.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65862-657-03 | 65862065703 | 3 BLISTER PACK in 1 CARTON (65862-657-03) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (65862-657-10) | 3 blister pack | 2014-05-15 | 0000-00-00 | No | No | Current |
| 65862-657-10 | 65862065710 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 65862-657-55 | 65862065755 | 15000 TABLET, ORALLY DISINTEGRATING in 1 BAG (65862-657-55) | | 15-MAY-14 | | | | Current |