OLANZAPINE
- Product NDC
- 13668-166
- 11-digit product format
- 136680166
- Labeler code
- 13668
- Product ID
- 13668-166_1a64829a-2434-4c8d-8e58-9b28758e4b88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OLANZAPINE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Torrent Pharmaceuticals Limited
- Application
- ANDA091434
- Marketing category
- ANDA
- Marketing start
- 2026-02-28
- Substance
- OLANZAPINE
- Active strength
- 2.5 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 | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | N7U69T4SZR |
| Rxcui | 200034, 283639, 312076, 312077, 312078, 312079, 314154, 314155, 351107, 351108 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OLANZAPINE | ACTIVE INGREDIENT | N7U69T4SZR | OLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [TORRENT PHARMACEUTICALS LIMITED] | 6 | |
| OLANZAPINE | ACTIVE MOIETY | N7U69T4SZR | OLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [TORRENT PHARMACEUTICALS LIMITED] | 6 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | OLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [TORRENT PHARMACEUTICALS LIMITED] | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | OLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [TORRENT PHARMACEUTICALS LIMITED] | 6 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | OLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [TORRENT PHARMACEUTICALS LIMITED] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | OLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [TORRENT PHARMACEUTICALS LIMITED] | 6 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | OLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [TORRENT PHARMACEUTICALS LIMITED] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13668-166 | OLANZAPINE TABLET OLANZAPINE TABLET, ORALLY DISINTEGRATING [TORRENT PHARMACEUTICALS LIMITED] | 17 | Current NDC, Legacy NDC, 6 package rows | 20250305_2cb1bebe-0ced-46d8-bf21-c28a9acc4a15.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 13668-166-01 | 13668016601 | 100 TABLET in 1 BOTTLE (13668-166-01) | 100 tablet | 2026-02-28 | No | No | Historical |
| 13668-166-05 | 13668016605 | 500 TABLET in 1 BOTTLE (13668-166-05) | 500 tablet | 2026-02-28 | No | No | Historical |
| 13668-166-10 | 13668016610 | 1000 TABLET in 1 BOTTLE (13668-166-10) | 1000 tablet | 2026-02-28 | No | No | Historical |
| 13668-166-30 | 13668016630 | 30 TABLET in 1 BOTTLE (13668-166-30) | 30 tablet | 2026-02-28 | No | No | Historical |
| 13668-166-43 | 13668016643 | 3000 TABLET in 1 BOTTLE (13668-166-43) | 3000 tablet | 2026-02-28 | No | No | Historical |
| 13668-166-60 | 13668016660 | 60 TABLET in 1 BOTTLE (13668-166-60) | 60 tablet | 2026-02-28 | No | No | Historical |