Olanzapine
- Product NDC
- 67184-0565
- 11-digit product format
- 671840565
- Labeler code
- 67184
- Product ID
- 67184-0565_69558fe2-90b3-411a-89bb-2405d37d4998
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olanzapine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Qilu Pharmaceutical Co., Ltd.
- Application
- ANDA204319
- Marketing category
- ANDA
- Marketing start
- 2016-01-27
- 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 | 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 |
|---|
| 67184-0565-1 | Olanzapine | 30 in 1 BOTTLE | TABLET | 30 | | 5 |
| 67184-0565-2 | Olanzapine | 100 in 1 BOTTLE | TABLET | 100 | | 5 |
| 67184-0565-4 | Olanzapine | 800 in 1 BOTTLE | TABLET | 800 | | 5 |
| 67184-0565-6 | Olanzapine | 90 in 1 BOTTLE | TABLET | 90 | | 5 |
| 67184-0565-7 | Olanzapine | 500 in 1 BOTTLE | TABLET | 500 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67184-0565 | OLANZAPINE TABLET [QILU PHARMACEUTICAL CO., LTD.] | 5 | Current NDC, Legacy NDC, 5 package rows | 20240827_6077f5c4-01d7-4c1d-97a0-cb859f98ce68.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 67184-0565-1 | 67184056501 | 30 in 1 BOTTLE | Historical |
| 67184-0565-2 | 67184056502 | 100 in 1 BOTTLE | Historical |
| 67184-0565-4 | 67184056504 | 800 in 1 BOTTLE | Historical |
| 67184-0565-6 | 67184056506 | 90 in 1 BOTTLE | Historical |
| 67184-0565-7 | 67184056507 | 500 in 1 BOTTLE | Historical |