Olanzapine
- Product NDC
- 71335-0534
- 11-digit product format
- 713350534
- Labeler code
- 71335
- Product ID
- 71335-0534_337b1be2-1abe-ac1f-e063-6294a90a13a7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olanzapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA202862
- Marketing category
- ANDA
- Marketing start
- 2014-08-22
- 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| N7U69T4SZR | OLANZAPINE | 132539-06-1 | OLANZAPINE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-0534-1 | 71335053401 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-0534-1) | 2018-02-21 | No | No | Historical |
| 71335-0534-2 | 71335053402 | 15 TABLET, FILM COATED in 1 BOTTLE (71335-0534-2) | 2021-12-27 | No | No | Historical |
| 71335-0534-3 | 71335053403 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-0534-3) | 2021-06-01 | No | No | Historical |
| 71335-0534-4 | 71335053404 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-0534-4) | 2021-12-27 | No | No | Historical |
| 71335-0534-5 | 71335053405 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-0534-5) | 2021-12-27 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Olanzapine | Bryant Ranch Prepack | 2025-04-23 | HUMAN PRESCRIPTION DRUG LABEL | 14 |