Olanzapine
- Product NDC
- 71610-419
- 11-digit product format
- 716100419
- Labeler code
- 71610
- Product ID
- 71610-419_de72ce02-c9dd-4462-aca5-87fb4427c78a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olanzapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA090798
- Marketing category
- ANDA
- Marketing start
- 2012-04-23
- Substance
- OLANZAPINE
- Active strength
- 15 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 |
|---|
| 71610-419-30 | 71610041930 | 30 TABLET, FILM COATED in 1 BOTTLE (71610-419-30) | 2020-04-23 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Olanzapine | Aphena Pharma Solutions - Tennessee, LLC | 2020-05-05 | HUMAN PRESCRIPTION DRUG LABEL | 1 |