Olanzapine
- Product NDC
- 0093-5247
- 11-digit product format
- 000935247
- Labeler code
- 0093
- Product ID
- 0093-5247_379692bf-82b3-48f3-8d1f-5a27949ce441
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olanzapine
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA077243
- Marketing category
- ANDA
- Marketing start
- 2012-01-24
- Substance
- OLANZAPINE
- Active strength
- 15 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Olanzapine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OLANZAPINE | 15 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | N7U69T4SZR |
| Rxcui | 312076, 314155, 351107, 351108 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0093-5247-19 | Olanzapine | 1 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 1 | | 18 |
| 0093-5247-65 | Olanzapine | 30 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 30 | | 18 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OLANZAPINE | ACTIVE INGREDIENT | N7U69T4SZR | OLANZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC] | 6 | |
| OLANZAPINE | ACTIVE MOIETY | N7U69T4SZR | OLANZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC] | 6 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | OLANZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC] | 6 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | OLANZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC] | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | OLANZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC] | 6 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | OLANZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | OLANZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC] | 6 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | OLANZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC] | 6 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | OLANZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC] | 6 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | OLANZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC] | 6 | |
| XYLITOL | INACTIVE INGREDIENT | VCQ006KQ1E | OLANZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA INC] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0093-5247 | OLANZAPINE TABLET, ORALLY DISINTEGRATING [TEVA PHARMACEUTICALS USA, INC.] | 16 | Current NDC, Legacy NDC, 2 package rows | 20250418_dd0b2525-4e2f-44fc-9302-0ae4ebb1e135.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0093-5247-19 | 00093524719 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 0093-5247-65 | 00093524765 | 30 BLISTER PACK in 1 CARTON (0093-5247-65) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0093-5247-19) | 30 blister pack | 2012-02-24 | 0000-00-00 | No | No | Current |