Olanzapine
- Product NDC
- 69543-381
- 11-digit product format
- 695430381
- Labeler code
- 69543
- Product ID
- 69543-381_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
- 5 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 |
|---|---|---|---|---|---|
| 69543-381-30 | EA - Each | 69543-381 | a1f9646d-02c9-4b5a-9df2-f05145e37ad0 | 1 | 2018-02-20 |
| 69543-381-90 | EA - Each | 69543-381 | 0af0ed5d-63c2-406d-8dcf-f03096163861 | 1 | 2018-02-20 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 200034 | OLANZapine 2.5 MG Oral Tablet | PSN | 760a905c-548c-4d4f-ae4b-06624bf3f76f | 6 |
| 312078 | OLANZapine 5 MG Oral Tablet | PSN | 760a905c-548c-4d4f-ae4b-06624bf3f76f | 6 |
| 200034 | olanzapine 2.5 MG Oral Tablet | SCD | 760a905c-548c-4d4f-ae4b-06624bf3f76f | 6 |
| 312078 | olanzapine 5 MG Oral Tablet | SCD | 760a905c-548c-4d4f-ae4b-06624bf3f76f | 6 |
| 312078 | OLANZapine 5 MG Oral Tablet | PSN | 2289d967-9567-4231-8935-01082e68e78c | 3 |
| 312078 | olanzapine 5 MG Oral Tablet | SCD | 2289d967-9567-4231-8935-01082e68e78c | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69543-381-30 | 69543038130 | 30 TABLET in 1 BOTTLE (69543-381-30) | 30 tablet | 2018-01-19 | 0000-00-00 | No | No | Current |
| 69543-381-90 | 69543038190 | 90 TABLET in 1 BOTTLE (69543-381-90) | 90 tablet | 2018-01-19 | 0000-00-00 | No | No | Current |