Olanzapine
- Product NDC
- 64725-0955
- 11-digit product format
- 647250955
- Labeler code
- 64725
- Product ID
- 64725-0955_e66eb52e-210e-49f2-910d-38ac51616e63
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olanzapine
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- TYA Pharmaceuticals
- Application
- ANDA201741
- Marketing category
- ANDA
- Marketing start
- 2012-06-27
- 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 |
|---|
| 64725-0955-1 | Olanzapine | 1 mL in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 2 |
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 [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 |
|---|
| 64725-0955 | OLANZAPINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [TYA PHARMACEUTICALS] | 2 | Legacy NDC, 1 package rows | 20141110_591f9bb1-f119-4739-87b0-de29c9446727.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 64725-0955-1 | 64725095501 | 1 mL in 1 CARTON | 1 ml | Historical |