Olanzapine
- Product NDC
- 63187-340
- 11-digit product format
- 631870340
- Labeler code
- 63187
- Product ID
- 63187-340_c6e1cbe2-4d81-4b7c-b948-d64d9b3527a7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olanzapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA202862
- Marketing category
- ANDA
- Marketing start
- 2014-08-22
- Substance
- OLANZAPINE
- Active strength
- 5 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 | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | N7U69T4SZR |
| Rxcui | 312078 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-340-06 | Olanzapine | 6 in 1 BOTTLE | TABLET, FILM COATED | 6 | | 5 |
| 63187-340-30 | Olanzapine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 5 |
| 63187-340-60 | Olanzapine | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 5 |
| 63187-340-90 | Olanzapine | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 5 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OLANZAPINE | ACTIVE INGREDIENT | N7U69T4SZR | OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| OLANZAPINE | ACTIVE MOIETY | N7U69T4SZR | OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-340 | OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP] | 5 | Current NDC, Legacy NDC, 4 package rows | 20230225_ce66d545-015b-41d5-80c3-964d78e36bfd.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63187-340-06 | 63187034006 | 6 TABLET, FILM COATED in 1 BOTTLE (63187-340-06) | 2023-02-21 | | No | No | Current |
| 63187-340-30 | 63187034030 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-340-30) | 2015-02-02 | 0000-00-00 | No | No | Current |
| 63187-340-60 | 63187034060 | 60 TABLET, FILM COATED in 1 BOTTLE (63187-340-60) | 2023-02-21 | | No | No | Current |
| 63187-340-90 | 63187034090 | 90 TABLET, FILM COATED in 1 BOTTLE (63187-340-90) | 2023-02-21 | | No | No | Current |