Quetiapine
- Product NDC
- 42291-697
- 11-digit product format
- 422910697
- Labeler code
- 42291
- Product ID
- 42291-697_dfdbe5d8-398c-fa79-e053-2995a90a2f78
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA077745
- Marketing category
- ANDA
- Marketing start
- 2022-05-25
- Marketing end
- 0000-00-00
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 100 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 |
|---|---|---|---|
| 5ef42f82-f087-0d2c-105f-f791ca69210e | Product name | 8 | 20250729 |
| 21205abd-8c89-4943-9f85-908f3d4fc3bb | Product name | 5 | 20230501 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42291-697-10 | Quetiapine | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | 12 | |
| 42291-697-90 | Quetiapine | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 12 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312743 | QUEtiapine fumarate 100 MG Oral Tablet | PSN | 8a3fc038-aad1-6404-6ead-a4a55127cf43 | 12 |
| 317174 | QUEtiapine fumarate 200 MG Oral Tablet | PSN | 8a3fc038-aad1-6404-6ead-a4a55127cf43 | 12 |
| 312744 | QUEtiapine fumarate 25 MG Oral Tablet | PSN | 8a3fc038-aad1-6404-6ead-a4a55127cf43 | 12 |
| 312745 | QUEtiapine fumarate 300 MG Oral Tablet | PSN | 8a3fc038-aad1-6404-6ead-a4a55127cf43 | 12 |
| 616483 | QUEtiapine fumarate 400 MG Oral Tablet | PSN | 8a3fc038-aad1-6404-6ead-a4a55127cf43 | 12 |
| 616487 | QUEtiapine fumarate 50 MG Oral Tablet | PSN | 8a3fc038-aad1-6404-6ead-a4a55127cf43 | 12 |
| 312743 | quetiapine 100 MG Oral Tablet | SCD | 8a3fc038-aad1-6404-6ead-a4a55127cf43 | 12 |
| 317174 | quetiapine 200 MG Oral Tablet | SCD | 8a3fc038-aad1-6404-6ead-a4a55127cf43 | 12 |
| 312744 | quetiapine 25 MG Oral Tablet | SCD | 8a3fc038-aad1-6404-6ead-a4a55127cf43 | 12 |
| 312745 | quetiapine 300 MG Oral Tablet | SCD | 8a3fc038-aad1-6404-6ead-a4a55127cf43 | 12 |
| 616483 | quetiapine 400 MG Oral Tablet | SCD | 8a3fc038-aad1-6404-6ead-a4a55127cf43 | 12 |
| 616487 | quetiapine 50 MG Oral Tablet | SCD | 8a3fc038-aad1-6404-6ead-a4a55127cf43 | 12 |
| 312743 | quetiapine (as quetiapine fumarate) 100 MG Oral Tablet | SY | 8a3fc038-aad1-6404-6ead-a4a55127cf43 | 12 |
| 317174 | quetiapine (as quetiapine fumarate) 200 MG Oral Tablet | SY | 8a3fc038-aad1-6404-6ead-a4a55127cf43 | 12 |
| 312744 | quetiapine (as quetiapine fumarate) 25 MG Oral Tablet | SY | 8a3fc038-aad1-6404-6ead-a4a55127cf43 | 12 |
| 312745 | quetiapine (as quetiapine fumarate) 300 MG Oral Tablet | SY | 8a3fc038-aad1-6404-6ead-a4a55127cf43 | 12 |
| 616483 | quetiapine (as quetiapine fumarate) 400 MG Oral Tablet | SY | 8a3fc038-aad1-6404-6ead-a4a55127cf43 | 12 |
| 616487 | quetiapine (as quetiapine fumarate) 50 MG Oral Tablet | SY | 8a3fc038-aad1-6404-6ead-a4a55127cf43 | 12 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 42291-697-10 | 42291069710 | 1000 TABLET, FILM COATED in 1 BOTTLE (42291-697-10) | 2022-05-25 | 0000-00-00 | No | No | Current |
| 42291-697-90 | 42291069790 | 90 in 1 BOTTLE | Historical |