Olanzapine
- Product NDC
- 71209-077
- 11-digit product format
- 712090077
- Labeler code
- 71209
- Product ID
- 71209-077_a7f753c2-1d2b-4b4f-b0e5-250bf951e7c6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olanzapine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Cadila Pharmaceuticals Limited
- Application
- ANDA210022
- Marketing category
- ANDA
- Marketing start
- 2019-02-13
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71209-077-01 | Olanzapine | 30 in 1 BOTTLE | TABLET | 30 | | 8 |
| 71209-077-05 | Olanzapine | 100 in 1 BOTTLE | TABLET | 100 | | 8 |
| 71209-077-10 | Olanzapine | 500 in 1 BOTTLE | TABLET | 500 | | 8 |
| 71209-077-11 | Olanzapine | 1000 in 1 BOTTLE | TABLET | 1000 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71209-077 | OLANZAPINE TABLET [CADILA PHARMACEUTICALS LIMITED] | 8 | Current NDC, 4 package rows | 20250321_2ae07ad4-4e58-4740-9f02-035ec061fefc.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 |
|---|
| 71209-077-01 | 71209007701 | 30 TABLET in 1 BOTTLE (71209-077-01) | 30 tablet | 2019-02-13 | No | No | Historical |
| 71209-077-05 | 71209007705 | 100 TABLET in 1 BOTTLE (71209-077-05) | 100 tablet | 2023-10-04 | No | No | Historical |
| 71209-077-10 | 71209007710 | 500 TABLET in 1 BOTTLE (71209-077-10) | 500 tablet | 2023-10-04 | No | No | Historical |
| 71209-077-11 | 71209007711 | 1000 TABLET in 1 BOTTLE (71209-077-11) | 1000 tablet | 2019-02-13 | No | No | Historical |