Olanzapine
- Product NDC
- 0904-6286
- 11-digit product format
- 009046286
- Labeler code
- 0904
- Product ID
- 0904-6286_8f57a36a-6427-4da3-ad7d-59093754fb98
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olanzapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA076133
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Olanzapine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OLANZAPINE | 15 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | N7U69T4SZR |
| Rxcui | 283639, 312077 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-6286-06 | Olanzapine | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 14 |
| 0904-6286-06 | Olanzapine | 50 in 1 CARTON | TABLET, FILM COATED | 50 | | 14 |
| 0904-6286-61 | Olanzapine | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 14 |
| 0904-6286-61 | Olanzapine | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 14 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OLANZAPINE | ACTIVE INGREDIENT | N7U69T4SZR | OLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 6 | |
| OLANZAPINE | ACTIVE MOIETY | N7U69T4SZR | OLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | OLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 6 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | OLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 6 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | OLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 6 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | OLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 6 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | OLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | OLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 6 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | OLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 6 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | OLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-6286 | OLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 13 | Current NDC, Legacy NDC, 4 package rows | 20241115_709d79a1-2742-4629-af43-161be166833a.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 |
|---|
| 0904-6286-06 | 00904628606 | 50 BLISTER PACK in 1 CARTON (0904-6286-06) > 1 TABLET, FILM COATED in 1 BLISTER PACK | 50 blister pack | 2012-04-23 | 0000-00-00 | No | No | Current |
| 0904-6286-61 | 00904628661 | 100 BLISTER PACK in 1 CARTON (0904-6286-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 100 blister pack | 2012-04-23 | 0000-00-00 | No | No | Current |