Olanzapine
- Product NDC
- 43598-166
- 11-digit product format
- 435980166
- Labeler code
- 43598
- Product ID
- 43598-166_9f9b5830-1420-24fc-73be-4a040ccb22db
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olanzapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Inc.
- 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 | 312078, 312079, 314154 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43598-166-01 | Olanzapine | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 13 |
| 43598-166-05 | Olanzapine | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 13 |
| 43598-166-10 | Olanzapine | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 13 |
| 43598-166-30 | Olanzapine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 13 |
| 43598-166-60 | Olanzapine | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 13 |
| 43598-166-78 | Olanzapine | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 13 |
| 43598-166-79 | Olanzapine | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 13 |
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] | 7 | |
| OLANZAPINE | ACTIVE MOIETY | N7U69T4SZR | OLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 7 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | OLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 7 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | OLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 7 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | OLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 7 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | OLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 7 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | OLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | OLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 7 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | OLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 7 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | OLANZAPINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 7 | |
| olanzapine | ACTIVE INGREDIENT | N7U69T4SZR | OLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES INC] | 4 | |
| olanzapine | ACTIVE INGREDIENT | N7U69T4SZR | OLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 4 | |
| OLANZAPINE | ACTIVE MOIETY | N7U69T4SZR | OLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES INC] | 4 | |
| OLANZAPINE | ACTIVE MOIETY | N7U69T4SZR | OLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | OLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES INC] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | OLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 4 | |
| Crospovidone | INACTIVE INGREDIENT | 68401960MK | OLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES INC] | 4 | |
| Crospovidone | INACTIVE INGREDIENT | 68401960MK | OLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 4 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | OLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES INC] | 4 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | OLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 4 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | OLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 4 | |
| Hydroxypropyl Cellulose (Type H) | INACTIVE INGREDIENT | RFW2ET671P | OLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES INC] | 4 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | OLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 4 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | OLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES INC] | 4 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | OLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES INC] | 4 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | OLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 4 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | OLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 4 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | OLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES INC] | 4 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | OLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES INC] | 4 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | OLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 4 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | OLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES INC] | 4 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | OLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-166 | OLANZAPINE TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC.] | 13 | Current NDC, Legacy NDC, 7 package rows | 20250429_d474d5a9-d338-511d-5823-567c0a1bbf4d.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 |
|---|
| 43598-166-01 | 43598016601 | 100 TABLET, FILM COATED in 1 BOTTLE (43598-166-01) | | 2013-12-10 | 0000-00-00 | No | No | Current |
| 43598-166-05 | 43598016605 | 500 TABLET, FILM COATED in 1 BOTTLE (43598-166-05) | | 2013-12-10 | 0000-00-00 | No | No | Current |
| 43598-166-10 | 43598016610 | 1000 TABLET, FILM COATED in 1 BOTTLE (43598-166-10) | | 2013-12-10 | 0000-00-00 | No | No | Current |
| 43598-166-30 | 43598016630 | 30 TABLET, FILM COATED in 1 BOTTLE (43598-166-30) | | 2013-12-10 | 0000-00-00 | No | No | Current |
| 43598-166-60 | 43598016660 | 60 TABLET, FILM COATED in 1 BOTTLE (43598-166-60) | | 2013-12-10 | 0000-00-00 | No | No | Current |
| 43598-166-78 | 43598016678 | 10 BLISTER PACK in 1 CARTON (43598-166-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (43598-166-79) | 10 blister pack | 2013-12-10 | 0000-00-00 | No | No | Current |
| 43598-166-79 | 43598016679 | 10 in 1 BLISTER PACK | | | | | | Historical |