Olanzapine
- Product NDC
- 0527-3163
- 11-digit product format
- 005273163
- Labeler code
- 0527
- Product ID
- 0527-3163_002da62b-aec3-8e2a-e063-6294a90a5efc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olanzapine
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Lannett Company, Inc.
- Application
- ANDA208146
- Marketing category
- ANDA
- Marketing start
- 2023-05-30
- Substance
- OLANZAPINE
- Active strength
- 15 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 | 15 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 |
|---|
| 0527-3163-32 | Olanzapine | 30 in 1 BOTTLE, PLASTIC | TABLET, ORALLY DISINTEGRATING | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0527-3163 | OLANZAPINE TABLET, ORALLY DISINTEGRATING [LANNETT COMPANY, INC.] | 1 | Current NDC, 1 package rows | 20230711_002dd00f-7946-ea4f-e063-6294a90a5916.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0527-3163-32 | 00527316332 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0527-3163-32) | 2023-07-01 | No | No | Current |