Olanzapine
- Product NDC
- 68084-529
- 11-digit product format
- 680840529
- Labeler code
- 68084
- Product ID
- 68084-529_4b4696c5-89bf-9c39-e063-6294a90aebc1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olanzapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA076133
- Marketing category
- ANDA
- Marketing start
- 2012-05-08
- 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 | 283639, 312077 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68084-529-01 | Olanzapine | 100 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 100 | | 11 |
| 68084-529-11 | Olanzapine | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| olanzapine | ACTIVE INGREDIENT | N7U69T4SZR | OLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 4 | |
| OLANZAPINE | ACTIVE MOIETY | N7U69T4SZR | OLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | OLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 4 | |
| Crospovidone | INACTIVE INGREDIENT | 68401960MK | OLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 4 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | OLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 4 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | OLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 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 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | OLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 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 |
|---|
| 68084-529 | OLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 10 | Current NDC, Legacy NDC, 2 package rows | 20240522_c0d705bf-b719-4c7b-b83d-c17d41cbbfad.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 |
|---|
| 68084-529-01 | 68084052901 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-529-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-529-11) | 100 blister pack | 2012-05-08 | 0000-00-00 | No | No | Current |
| 68084-529-11 | 68084052911 | 1 in 1 BLISTER PACK | | | | | | Historical |