Olanzapine
- Product NDC
- 33342-086
- 11-digit product format
- 333420086
- Labeler code
- 33342
- Product ID
- 33342-086_54e61f27-1a30-4d62-8709-f7fe4023eb0f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olanzapine
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA203044
- Marketing category
- ANDA
- Marketing start
- 2015-02-27
- Substance
- OLANZAPINE
- Active strength
- 20 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 | 20 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 |
|---|
| 33342-086-07 | Olanzapine | 30 in 1 CONTAINER | TABLET, ORALLY DISINTEGRATING | 30 | | 12 |
| 33342-086-11 | Olanzapine | 100 in 1 CONTAINER | TABLET, ORALLY DISINTEGRATING | 100 | | 12 |
| 33342-086-12 | Olanzapine | 10 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 10 | | 12 |
| 33342-086-12 | Olanzapine | 10 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 10 | | 12 |
| 33342-086-15 | Olanzapine | 500 in 1 CONTAINER | TABLET, ORALLY DISINTEGRATING | 500 | | 12 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OLANZAPINE | ACTIVE INGREDIENT | N7U69T4SZR | OLANZAPINE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED] | 3 | |
| OLANZAPINE | ACTIVE MOIETY | N7U69T4SZR | OLANZAPINE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED] | 3 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | OLANZAPINE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | OLANZAPINE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED] | 3 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | OLANZAPINE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED] | 3 | |
| HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED | INACTIVE INGREDIENT | 2165RE0K14 | OLANZAPINE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | OLANZAPINE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33342-086 | OLANZAPINE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED] | 11 | Current NDC, Legacy NDC, 5 package rows | 20250312_df43938a-3469-40eb-8166-f0a2fd29d6d8.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 |
|---|
| 33342-086-07 | 33342008607 | 30 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-086-07) | | 2015-02-27 | 0000-00-00 | No | No | Current |
| 33342-086-11 | 33342008611 | 100 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-086-11) | | 2015-02-27 | 0000-00-00 | No | No | Current |
| 33342-086-12 | 33342008612 | 10 BLISTER PACK in 1 CARTON (33342-086-12) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 10 blister pack | 2015-02-27 | 0000-00-00 | No | No | Current |
| 33342-086-15 | 33342008615 | 500 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-086-15) | | 2015-02-27 | 0000-00-00 | No | No | Current |