Olanzapine
- Product NDC
- 64380-172
- 11-digit product format
- 643800172
- Labeler code
- 64380
- Product ID
- 64380-172_4b3cec46-acb7-4072-b226-d5c7c06b33b8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- olanzapine
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Strides Pharma Science Limited
- Application
- ANDA078109
- Marketing category
- ANDA
- Marketing start
- 2022-04-11
- 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 | 312076, 314155, 351107, 351108 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64380-172-01 | Olanzapine | 10 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 10 | | 5 |
| 64380-172-02 | Olanzapine | 3 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 3 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64380-172 | OLANZAPINE TABLET, ORALLY DISINTEGRATING [STRIDES PHARMA SCIENCE LIMITED] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250226_979c3212-36e8-4287-aace-bef0875188d7.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 |
|---|
| 64380-172-01 | 64380017201 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 64380-172-02 | 64380017202 | 3 BLISTER PACK in 1 CARTON (64380-172-02) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (64380-172-01) | 3 blister pack | 2022-04-11 | 0000-00-00 | No | No | Current |