Olanzapine
- Product NDC
- 71335-2627
- 11-digit product format
- 713352627
- Labeler code
- 71335
- Product ID
- 71335-2627_bdb8dfd3-6c84-491b-962b-becf607b42f0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olanzapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA076255
- Marketing category
- ANDA
- Marketing start
- 2013-12-10
- Substance
- OLANZAPINE
- Active strength
- 10 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | N7U69T4SZR |
| Rxcui | 314154 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2627-1 | 71335262701 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2627-1) | 2025-06-02 | No | No | Historical |
| 71335-2627-2 | 71335262702 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2627-2) | 2025-06-02 | No | No | Historical |
| 71335-2627-3 | 71335262703 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2627-3) | 2025-06-02 | No | No | Historical |