OLANZAPINE
- Product NDC
- 72303-0840
- 11-digit product format
- 723030840
- Labeler code
- 72303
- Product ID
- 72303-0840_4d2e9776-65f4-cb00-e063-6394a90a1bf7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olanzapine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- HEC Pharm USA Inc.
- Application
- ANDA206238
- Marketing category
- ANDA
- Marketing start
- 2018-11-30
- Substance
- OLANZAPINE
- Active strength
- 20 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 | 20 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 |
|---|---|---|---|---|---|---|
| 72303-0840-1 | OLANZAPINE | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 72303-0840-1 | EA - Each | 72303-0840 | 625fb3e0-2e48-45ba-b5cb-5caab5ee8d32 | 1 | 2026-05-22 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 314154 | OLANZapine 10 MG Oral Tablet | PSN | 4d34f8f3-edc8-0a68-e063-6394a90a9c1f | 1 |
| 312077 | OLANZapine 15 MG Oral Tablet | PSN | 4d34f8f3-edc8-0a68-e063-6394a90a9c1f | 1 |
| 200034 | OLANZapine 2.5 MG Oral Tablet | PSN | 4d34f8f3-edc8-0a68-e063-6394a90a9c1f | 1 |
| 283639 | OLANZapine 20 MG Oral Tablet | PSN | 4d34f8f3-edc8-0a68-e063-6394a90a9c1f | 1 |
| 312078 | OLANZapine 5 MG Oral Tablet | PSN | 4d34f8f3-edc8-0a68-e063-6394a90a9c1f | 1 |
| 312079 | OLANZapine 7.5 MG Oral Tablet | PSN | 4d34f8f3-edc8-0a68-e063-6394a90a9c1f | 1 |
| 314154 | olanzapine 10 MG Oral Tablet | SCD | 4d34f8f3-edc8-0a68-e063-6394a90a9c1f | 1 |
| 312077 | olanzapine 15 MG Oral Tablet | SCD | 4d34f8f3-edc8-0a68-e063-6394a90a9c1f | 1 |
| 200034 | olanzapine 2.5 MG Oral Tablet | SCD | 4d34f8f3-edc8-0a68-e063-6394a90a9c1f | 1 |
| 283639 | olanzapine 20 MG Oral Tablet | SCD | 4d34f8f3-edc8-0a68-e063-6394a90a9c1f | 1 |
| 312078 | olanzapine 5 MG Oral Tablet | SCD | 4d34f8f3-edc8-0a68-e063-6394a90a9c1f | 1 |
| 312079 | olanzapine 7.5 MG Oral Tablet | SCD | 4d34f8f3-edc8-0a68-e063-6394a90a9c1f | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 72303-0840-1 | 72303084001 | 30 TABLET in 1 BOTTLE, PLASTIC (72303-0840-1) | 30 tablet | 2018-11-30 | No | No | Current |