Olanzapine
- Product NDC
- 53002-2505
- 11-digit product format
- 530022505
- Labeler code
- 53002
- Product ID
- 53002-2505_ca71e01b-a505-4b8c-b391-99b6eaa1a4d8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olanzapine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA204319
- Marketing category
- ANDA
- Marketing start
- 2018-01-19
- Marketing end
- 0000-00-00
- Substance
- OLANZAPINE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-2505-3 | Olanzapine | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-2505 | OLANZAPINE TABLET [RPK PHARMACEUTICALS, INC.] | 3 | Legacy NDC, 1 package rows | 20230609_2289d967-9567-4231-8935-01082e68e78c.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 |
|---|
| 53002-2505-3 | 53002250503 | 30 TABLET in 1 BOTTLE (53002-2505-3) | 30 tablet | 2019-01-01 | 0000-00-00 | No | No | Current |