OLANZAPINE
- Product NDC
- 50268-616
- 11-digit product format
- 502680616
- Labeler code
- 50268
- Product ID
- 50268-616_d5de9d7e-79e3-5f96-e053-2995a90a3079
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OLANZAPINE
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- AvPAK
- Application
- ANDA091415
- Marketing category
- ANDA
- Marketing start
- 2014-04-23
- Marketing end
- 0000-00-00
- Substance
- OLANZAPINE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OLANZAPINE | ACTIVE INGREDIENT | N7U69T4SZR | OLANZAPINE (OLANZAPINE) TABLET, ORALLY DISINTEGRATING [AVPAK] | 4 | |
| OLANZAPINE | ACTIVE MOIETY | N7U69T4SZR | OLANZAPINE (OLANZAPINE) TABLET, ORALLY DISINTEGRATING [AVPAK] | 4 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | OLANZAPINE (OLANZAPINE) TABLET, ORALLY DISINTEGRATING [AVPAK] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | OLANZAPINE (OLANZAPINE) TABLET, ORALLY DISINTEGRATING [AVPAK] | 4 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | OLANZAPINE (OLANZAPINE) TABLET, ORALLY DISINTEGRATING [AVPAK] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | OLANZAPINE (OLANZAPINE) TABLET, ORALLY DISINTEGRATING [AVPAK] | 4 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | OLANZAPINE (OLANZAPINE) TABLET, ORALLY DISINTEGRATING [AVPAK] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50268-616 | OLANZAPINE TABLET, ORALLY DISINTEGRATING [AVPAK] | 11 | Legacy NDC | 20250112_98697cfd-5521-f8a9-af17-555031690b08.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50268-616-13 | 50268061613 | 30 BLISTER PACK in 1 BOX (50268-616-13) > 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (50268-616-11) | 30 blister pack | 2014-04-23 | 0000-00-00 | No | No | Current |