Olanzapine
- Product NDC
- 69543-383
- 11-digit product format
- 695430383
- Labeler code
- 69543
- Product ID
- 69543-383_e78e66e4-82ab-47a9-8633-d304cb6bac1e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olanzapine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Virtus Pharmaceuticals, LLC
- Application
- ANDA204319
- Marketing category
- ANDA
- Marketing start
- 2018-01-19
- 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 Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 42e9462d-db65-453b-8069-8fb2df9182e8 | Product name | 1 | 20211216 |
| 12d02c27-e8da-47f1-b815-ccca982731ef | Product name | 9 | 20170802 |
| 877783eb-030c-6e3f-0979-804cf94d8856 | Product name | 1 | 20140508 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69543-383-30 | EA - Each | 69543-383 | f4217873-beb1-48f6-95e5-439c7441c50e | 1 | 2018-02-20 |
| 69543-383-90 | EA - Each | 69543-383 | f1fd408e-2338-41df-acac-dd82a7cb3290 | 1 | 2018-02-20 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 314154 | OLANZapine 10 MG Oral Tablet | PSN | 78fc032d-d6f4-4953-9a35-ac386f62e232 | 4 |
| 314154 | olanzapine 10 MG Oral Tablet | SCD | 78fc032d-d6f4-4953-9a35-ac386f62e232 | 4 |
| 314154 | OLANZapine 10 MG Oral Tablet | PSN | 534566ac-7174-4354-a1ee-24b144a5d660 | 2 |
| 314154 | olanzapine 10 MG Oral Tablet | SCD | 534566ac-7174-4354-a1ee-24b144a5d660 | 2 |
| 314154 | OLANZapine 10 MG Oral Tablet | PSN | c1cb3de5-7bee-4baa-9128-1d5062067482 | 1 |
| 314154 | olanzapine 10 MG Oral Tablet | SCD | c1cb3de5-7bee-4baa-9128-1d5062067482 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69543-383-30 | 69543038330 | 30 TABLET in 1 BOTTLE (69543-383-30) | 30 tablet | 2018-01-19 | 0000-00-00 | No | No | Current |
| 69543-383-90 | 69543038390 | 90 TABLET in 1 BOTTLE (69543-383-90) | 90 tablet | 2018-01-19 | 0000-00-00 | No | No | Current |