Olanzapine
- Product NDC
- 0517-0955
- 11-digit product format
- 005170955
- Labeler code
- 0517
- Product ID
- 0517-0955_9e02e2b0-cac8-4917-ad26-6d70e86f1b30
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olanzapine
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- American Regent, Inc.
- Application
- ANDA201741
- Marketing category
- ANDA
- Marketing start
- 2012-06-27
- Substance
- OLANZAPINE
- Active strength
- 10 mg/2mL
- 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/2mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | N7U69T4SZR |
| Rxcui | 485968 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0517-0955-01 | Olanzapine | 2 mL in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 2 | | 17 |
| 0517-0955-01 | Olanzapine | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 17 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OLANZAPINE | ACTIVE INGREDIENT | N7U69T4SZR | OLANZAPINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMERICAN REGENT, INC.] | 4 | |
| OLANZAPINE | ACTIVE MOIETY | N7U69T4SZR | OLANZAPINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMERICAN REGENT, INC.] | 4 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | OLANZAPINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMERICAN REGENT, INC.] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | OLANZAPINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMERICAN REGENT, INC.] | 4 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | OLANZAPINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMERICAN REGENT, INC.] | 4 | |
| TARTARIC ACID | INACTIVE INGREDIENT | W4888I119H | OLANZAPINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMERICAN REGENT, INC.] | 4 | |
| OLANZAPINE | ACTIVE INGREDIENT | N7U69T4SZR | OLANZAPINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [TYA PHARMACEUTICALS] | 2 | |
| OLANZAPINE | ACTIVE MOIETY | N7U69T4SZR | OLANZAPINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [TYA PHARMACEUTICALS] | 2 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | OLANZAPINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [TYA PHARMACEUTICALS] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | OLANZAPINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [TYA PHARMACEUTICALS] | 2 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | OLANZAPINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [TYA PHARMACEUTICALS] | 2 | |
| TARTARIC ACID | INACTIVE INGREDIENT | W4888I119H | OLANZAPINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [TYA PHARMACEUTICALS] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0517-0955 | OLANZAPINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMERICAN REGENT, INC.] | 16 | Current NDC, Legacy NDC, 2 package rows | 20240420_e9ac2bd3-dbff-4b1a-952f-da3909c6e4ee.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0517-0955-01 | 00517095501 | 1 VIAL, GLASS in 1 CARTON (0517-0955-01) / 2 mL in 1 VIAL, GLASS | 2012-06-27 | 0000-00-00 | No | No | Current |