Olanzapine
- Product NDC
- 72789-460
- 11-digit product format
- 727890460
- Labeler code
- 72789
- Product ID
- 72789-460_3840298a-c3c2-01b5-e063-6394a90a0a60
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olanzapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA076255
- Marketing category
- ANDA
- Marketing start
- 2013-12-10
- Substance
- OLANZAPINE
- Active strength
- 5 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 | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | N7U69T4SZR |
| Rxcui | 312078 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72789-460-14 | Olanzapine | 14 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 14 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-460 | OLANZAPINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 13 | Current NDC, 1 package rows | 20241222_10043041-a632-4e57-bc08-37216dea8546.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72789-460-14 | 72789046014 | 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-460-14) | 2024-12-20 | No | No | Current |