Olanzapine
- Product NDC
- 67877-176
- 11-digit product format
- 678770176
- Labeler code
- 67877
- Product ID
- 67877-176_b4d4d6f0-2b78-4882-add2-7c6218270b7f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olanzapine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA202295
- Marketing category
- ANDA
- Marketing start
- 2012-01-01
- 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 | 200034, 283639, 312077, 312078, 312079, 314154 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 67877-176-01 | 2022-10-31 | C162847 | 48780-1 | 9d75b9d0-224b-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996 |
| 67877-176-10 | 2022-10-31 | C162847 | 48780-1 | 9d75b9d0-224b-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996 |
| 67877-176-30 | 2022-10-31 | C162847 | 48780-1 | 9d75b9d0-224b-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996 |
| 67877-176-32 | 2022-10-31 | C162847 | 48780-1 | 9d75b9d0-224b-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996 |
| 67877-176-35 | 2022-10-31 | C162847 | 48780-1 | 9d75b9d0-224b-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996 |
| 67877-176-85 | 2022-10-31 | C162847 | 48780-1 | 9d75b9d0-224b-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996 |
| 67877-176-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-224b-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996 |
| 67877-176-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-224b-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996 |
| 67877-176-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-224b-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996 |
| 67877-176-32 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-224b-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996 |
| 67877-176-35 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-224b-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996 |
| 67877-176-85 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-224b-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996 |
DailyMed Package Descriptions#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OLANZAPINE | ACTIVE INGREDIENT | N7U69T4SZR | OLANZAPINE TABLET [ASCEND LABORATORIES, LLC] | 7 | |
| OLANZAPINE | ACTIVE MOIETY | N7U69T4SZR | OLANZAPINE TABLET [ASCEND LABORATORIES, LLC] | 7 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | OLANZAPINE TABLET [ASCEND LABORATORIES, LLC] | 7 | |
| BUTYL ALCOHOL | INACTIVE INGREDIENT | 8PJ61P6TS3 | OLANZAPINE TABLET [ASCEND LABORATORIES, LLC] | 7 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | OLANZAPINE TABLET [ASCEND LABORATORIES, LLC] | 7 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | OLANZAPINE TABLET [ASCEND LABORATORIES, LLC] | 7 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | OLANZAPINE TABLET [ASCEND LABORATORIES, LLC] | 7 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | OLANZAPINE TABLET [ASCEND LABORATORIES, LLC] | 7 | |
| HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED | INACTIVE INGREDIENT | 2165RE0K14 | OLANZAPINE TABLET [ASCEND LABORATORIES, LLC] | 7 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | OLANZAPINE TABLET [ASCEND LABORATORIES, LLC] | 7 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | OLANZAPINE TABLET [ASCEND LABORATORIES, LLC] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | OLANZAPINE TABLET [ASCEND LABORATORIES, LLC] | 7 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | OLANZAPINE TABLET [ASCEND LABORATORIES, LLC] | 7 | |
| PECTIN | INACTIVE INGREDIENT | 89NA02M4RX | OLANZAPINE TABLET [ASCEND LABORATORIES, LLC] | 7 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | OLANZAPINE TABLET [ASCEND LABORATORIES, LLC] | 7 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | OLANZAPINE TABLET [ASCEND LABORATORIES, LLC] | 7 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | OLANZAPINE TABLET [ASCEND LABORATORIES, LLC] | 7 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | OLANZAPINE TABLET [ASCEND LABORATORIES, LLC] | 7 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | OLANZAPINE TABLET [ASCEND LABORATORIES, LLC] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67877-176 | OLANZAPINE TABLET [ASCEND LABORATORIES, LLC] | 9 | Current NDC, Legacy NDC, 7 package rows | 20221101_e8626e68-088d-47ff-bf06-489a778815aa.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 |
|---|
| 67877-176-01 | 67877017601 | 100 TABLET in 1 BOTTLE (67877-176-01) | 100 tablet | 2012-01-01 | 0000-00-00 | No | No | Current |
| 67877-176-10 | 67877017610 | 1000 TABLET in 1 BOTTLE (67877-176-10) | 1000 tablet | 2012-01-01 | 0000-00-00 | No | No | Current |
| 67877-176-30 | 67877017630 | 30 TABLET in 1 BOTTLE (67877-176-30) | 30 tablet | 2012-01-01 | 0000-00-00 | No | No | Current |
| 67877-176-32 | 67877017632 | 7 TABLET in 1 BOTTLE (67877-176-32) | 7 tablet | 2012-01-01 | 0000-00-00 | No | No | Current |
| 67877-176-33 | 67877017633 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 67877-176-35 | 67877017635 | 10 BLISTER PACK in 1 CARTON (67877-176-35) / 10 TABLET in 1 BLISTER PACK (67877-176-33) | 10 blister pack | 2012-01-01 | 0000-00-00 | No | No | Current |
| 67877-176-85 | 67877017685 | 3 BLISTER PACK in 1 CARTON (67877-176-85) / 10 TABLET in 1 BLISTER PACK (67877-176-33) | 3 blister pack | 2012-01-01 | 0000-00-00 | No | No | Current |