Olanzapine
- Product NDC
- 64725-0552
- 11-digit product format
- 647250552
- Labeler code
- 64725
- Product ID
- 64725-0552_c7d79e6a-46cb-4ba7-bcb4-510604307cd1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olanzapine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- TYA Pharmaceuticals
- Application
- ANDA091038
- Marketing category
- ANDA
- Marketing start
- 2012-04-23
- Marketing end
- 0000-00-00
- Substance
- OLANZAPINE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 64725-0552-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-0d84-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use olanzapine safely and effectively. See full prescribing information for olanzapine tablets. Olanzapine Tablets, for Oral use Initial U.S. Approval: 1996 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64725-0552-1 | Olanzapine | 30 in 1 BOTTLE | TABLET | 30 | 7 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| OLANZAPINE | ACTIVE INGREDIENT | N7U69T4SZR | OLANZAPINE TABLET [TYA PHARMACEUTICALS] | 7 | |
| OLANZAPINE | ACTIVE MOIETY | N7U69T4SZR | OLANZAPINE TABLET [TYA PHARMACEUTICALS] | 7 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | OLANZAPINE TABLET [TYA PHARMACEUTICALS] | 7 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | OLANZAPINE TABLET [TYA PHARMACEUTICALS] | 7 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | OLANZAPINE TABLET [TYA PHARMACEUTICALS] | 7 | |
| HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED | INACTIVE INGREDIENT | 2165RE0K14 | OLANZAPINE TABLET [TYA PHARMACEUTICALS] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | OLANZAPINE TABLET [TYA PHARMACEUTICALS] | 7 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | OLANZAPINE TABLET [TYA PHARMACEUTICALS] | 7 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 64725-0552 | OLANZAPINE TABLET [TYA PHARMACEUTICALS] | 7 | Legacy NDC, 1 package rows | 20141102_fa6d5546-9bcd-4f4c-9751-15cccc665313.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 314154 | OLANZapine 10 MG Oral Tablet | PSN | fa6d5546-9bcd-4f4c-9751-15cccc665313 | 7 |
| 312077 | OLANZapine 15 MG Oral Tablet | PSN | fa6d5546-9bcd-4f4c-9751-15cccc665313 | 7 |
| 312078 | OLANZapine 5 MG Oral Tablet | PSN | fa6d5546-9bcd-4f4c-9751-15cccc665313 | 7 |
| 314154 | olanzapine 10 MG Oral Tablet | SCD | fa6d5546-9bcd-4f4c-9751-15cccc665313 | 7 |
| 312077 | olanzapine 15 MG Oral Tablet | SCD | fa6d5546-9bcd-4f4c-9751-15cccc665313 | 7 |
| 312078 | olanzapine 5 MG Oral Tablet | SCD | fa6d5546-9bcd-4f4c-9751-15cccc665313 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 64725-0552-1 | 64725055201 | 30 in 1 BOTTLE | Historical |