Olanzapine
- Product NDC
- 72603-159
- 11-digit product format
- 726030159
- Labeler code
- 72603
- Product ID
- 72603-159_bfaf4fef-69a8-40e1-b995-899044ad4a39
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olanzapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NorthStar RxLLC
- Application
- ANDA202862
- Marketing category
- ANDA
- Marketing start
- 2023-07-05
- Substance
- OLANZAPINE
- Active strength
- 20 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 | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | N7U69T4SZR |
| Rxcui | 200034, 283639, 312077, 312078, 312079, 314154 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72603-159-01 | Olanzapine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 72603-159-02 | Olanzapine | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 2 |
| 72603-159-03 | Olanzapine | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72603-159 | OLANZAPINE TABLET, FILM COATED [NORTHSTAR RXLLC] | 2 | Current NDC, 3 package rows | 20240711_ea3259d5-36ee-4ac9-b849-9625626e2187.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72603-159-01 | 72603015901 | 30 TABLET, FILM COATED in 1 BOTTLE (72603-159-01) | 2023-07-05 | No | No | Current |
| 72603-159-02 | 72603015902 | 500 TABLET, FILM COATED in 1 BOTTLE (72603-159-02) | 2023-07-05 | No | No | Current |
| 72603-159-03 | 72603015903 | 1000 TABLET, FILM COATED in 1 BOTTLE (72603-159-03) | 2023-07-05 | No | No | Current |