Olanzapine
- Product NDC
- 64725-3159
- 11-digit product format
- 647253159
- Labeler code
- 64725
- Product ID
- 64725-3159_5b3c9704-3969-4194-8861-afdf5b27491a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olanzapine
- Dosage form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- TYA Pharmaceuticals
- Application
- ANDA201588
- Marketing category
- ANDA
- Marketing start
- 2011-10-24
- Marketing end
- 0000-00-00
- Substance
- OLANZAPINE
- Active strength
- 10 mg/2mL
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 |
|---|
| 64725-3159-1 | Olanzapine | 10 mL in 1 VIAL | INJECTION, POWDER, FOR SOLUTION | 10 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OLANZAPINE | ACTIVE INGREDIENT | N7U69T4SZR | OLANZAPINE INJECTION, POWDER, FOR SOLUTION [TYA PHARMACEUTICALS] | 2 | |
| OLANZAPINE | ACTIVE MOIETY | N7U69T4SZR | OLANZAPINE INJECTION, POWDER, FOR SOLUTION [TYA PHARMACEUTICALS] | 2 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | OLANZAPINE INJECTION, POWDER, FOR SOLUTION [TYA PHARMACEUTICALS] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | OLANZAPINE INJECTION, POWDER, FOR SOLUTION [TYA PHARMACEUTICALS] | 2 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | OLANZAPINE INJECTION, POWDER, FOR SOLUTION [TYA PHARMACEUTICALS] | 2 | |
| TARTARIC ACID | INACTIVE INGREDIENT | W4888I119H | OLANZAPINE INJECTION, POWDER, FOR SOLUTION [TYA PHARMACEUTICALS] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64725-3159 | OLANZAPINE INJECTION, POWDER, FOR SOLUTION [TYA PHARMACEUTICALS] | 2 | Legacy NDC, 1 package rows | 20140927_3b3bc948-161e-49ee-b67f-4bbb63af23d6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 64725-3159-1 | 64725315901 | 10 mL in 1 VIAL | 10 ml | Historical |