Olanzapine
- Product NDC
- 65862-563
- 11-digit product format
- 658620563
- Labeler code
- 65862
- Product ID
- 65862-563_e10b90de-4a0a-413e-a5f9-6978a183b568
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olanzapine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA202050
- Marketing category
- ANDA
- Marketing start
- 2012-04-23
- Substance
- OLANZAPINE
- Active strength
- 7.5 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Olanzapine
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OLANZAPINE | 7.5 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | N7U69T4SZR |
| Rxcui | 200034, 283639, 312077, 312078, 312079, 314154 |
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 Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65862-563-01 | Olanzapine | 100 in 1 BOTTLE | TABLET | 100 | 21 | |
| 65862-563-05 | Olanzapine | 500 in 1 BOTTLE | TABLET | 500 | 21 | |
| 65862-563-10 | Olanzapine | 10 in 1 CARTON | TABLET | 10 | 21 | |
| 65862-563-10 | Olanzapine | 10 in 1 BLISTER PACK | TABLET | 10 | 21 | |
| 65862-563-30 | Olanzapine | 30 in 1 BOTTLE | TABLET | 30 | 21 | |
| 65862-563-99 | Olanzapine | 1000 in 1 BOTTLE | TABLET | 1000 | 21 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65862-563-30 | EA - Each | 65862-563 | 3aa51d84-dbcd-4aac-bad0-922d6f46b615 | 1 | 2012-07-24 |
| 65862-563-99 | EA - Each | 65862-563 | c06387b0-99f0-458b-9d64-b030fbf3e792 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| OLANZAPINE | ACTIVE INGREDIENT | N7U69T4SZR | OLANZAPINE TABLET [AUROBINDO PHARMA LIMITED] | 6 | |
| OLANZAPINE | ACTIVE MOIETY | N7U69T4SZR | OLANZAPINE TABLET [AUROBINDO PHARMA LIMITED] | 6 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | OLANZAPINE TABLET [AUROBINDO PHARMA LIMITED] | 6 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | OLANZAPINE TABLET [AUROBINDO PHARMA LIMITED] | 6 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | OLANZAPINE TABLET [AUROBINDO PHARMA LIMITED] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | OLANZAPINE TABLET [AUROBINDO PHARMA LIMITED] | 6 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 314154 | OLANZapine 10 MG Oral Tablet | PSN | 636665be-9d7e-443a-8134-e8cc47e6ba24 | 21 |
| 312077 | OLANZapine 15 MG Oral Tablet | PSN | 636665be-9d7e-443a-8134-e8cc47e6ba24 | 21 |
| 200034 | OLANZapine 2.5 MG Oral Tablet | PSN | 636665be-9d7e-443a-8134-e8cc47e6ba24 | 21 |
| 283639 | OLANZapine 20 MG Oral Tablet | PSN | 636665be-9d7e-443a-8134-e8cc47e6ba24 | 21 |
| 312078 | OLANZapine 5 MG Oral Tablet | PSN | 636665be-9d7e-443a-8134-e8cc47e6ba24 | 21 |
| 312079 | OLANZapine 7.5 MG Oral Tablet | PSN | 636665be-9d7e-443a-8134-e8cc47e6ba24 | 21 |
| 314154 | olanzapine 10 MG Oral Tablet | SCD | 636665be-9d7e-443a-8134-e8cc47e6ba24 | 21 |
| 312077 | olanzapine 15 MG Oral Tablet | SCD | 636665be-9d7e-443a-8134-e8cc47e6ba24 | 21 |
| 200034 | olanzapine 2.5 MG Oral Tablet | SCD | 636665be-9d7e-443a-8134-e8cc47e6ba24 | 21 |
| 283639 | olanzapine 20 MG Oral Tablet | SCD | 636665be-9d7e-443a-8134-e8cc47e6ba24 | 21 |
| 312078 | olanzapine 5 MG Oral Tablet | SCD | 636665be-9d7e-443a-8134-e8cc47e6ba24 | 21 |
| 312079 | olanzapine 7.5 MG Oral Tablet | SCD | 636665be-9d7e-443a-8134-e8cc47e6ba24 | 21 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 65862-563-01 | 65862056301 | 100 TABLET in 1 BOTTLE (65862-563-01) | 100 tablet | 2012-04-23 | 0000-00-00 | No | No | Current |
| 65862-563-05 | 65862056305 | 500 TABLET in 1 BOTTLE (65862-563-05) | 500 tablet | 2012-04-23 | 0000-00-00 | No | No | Current |
| 65862-563-10 | 65862056310 | 10 BLISTER PACK in 1 CARTON (65862-563-10) / 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2012-04-23 | 0000-00-00 | No | No | Current |
| 65862-563-30 | 65862056330 | 30 TABLET in 1 BOTTLE (65862-563-30) | 30 tablet | 2012-04-23 | 0000-00-00 | No | No | Current |
| 65862-563-99 | 65862056399 | 1000 TABLET in 1 BOTTLE (65862-563-99) | 1000 tablet | 2012-04-23 | 0000-00-00 | No | No | Current |