quetiapine fumarate
- Product NDC
- 60429-416
- 11-digit product format
- 604290416
- Labeler code
- 60429
- Product ID
- 60429-416_ba8a8283-0880-2756-e053-2995a90ab673
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- quetiapine fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Golden State Medical Supply, Inc.
- Application
- ANDA090960
- Marketing category
- ANDA
- Marketing start
- 2012-03-27
- Marketing end
- 0000-00-00
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60429-416-01 | EA - Each | 60429-416 | 2a5cb038-1720-4cce-8ce3-d8bbf6c2a907 | 1 | 2016-02-04 |
| 60429-416-10 | EA - Each | 60429-416 | 6fc65fdc-4361-4cc2-b61b-735eb70f1b37 | 1 | 2016-02-04 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312743 | QUEtiapine fumarate 100 MG Oral Tablet | PSN | 448cbd68-ab4f-447c-8e47-0f874fb5bcb4 | 1 |
| 317174 | QUEtiapine fumarate 200 MG Oral Tablet | PSN | 448cbd68-ab4f-447c-8e47-0f874fb5bcb4 | 1 |
| 312744 | QUEtiapine fumarate 25 MG Oral Tablet | PSN | 448cbd68-ab4f-447c-8e47-0f874fb5bcb4 | 1 |
| 312745 | QUEtiapine fumarate 300 MG Oral Tablet | PSN | 448cbd68-ab4f-447c-8e47-0f874fb5bcb4 | 1 |
| 312743 | quetiapine 100 MG Oral Tablet | SCD | 448cbd68-ab4f-447c-8e47-0f874fb5bcb4 | 1 |
| 317174 | quetiapine 200 MG Oral Tablet | SCD | 448cbd68-ab4f-447c-8e47-0f874fb5bcb4 | 1 |
| 312744 | quetiapine 25 MG Oral Tablet | SCD | 448cbd68-ab4f-447c-8e47-0f874fb5bcb4 | 1 |
| 312745 | quetiapine 300 MG Oral Tablet | SCD | 448cbd68-ab4f-447c-8e47-0f874fb5bcb4 | 1 |
| 312743 | quetiapine (as quetiapine fumarate) 100 MG Oral Tablet | SY | 448cbd68-ab4f-447c-8e47-0f874fb5bcb4 | 1 |
| 317174 | quetiapine (as quetiapine fumarate) 200 MG Oral Tablet | SY | 448cbd68-ab4f-447c-8e47-0f874fb5bcb4 | 1 |
| 312744 | quetiapine (as quetiapine fumarate) 25 MG Oral Tablet | SY | 448cbd68-ab4f-447c-8e47-0f874fb5bcb4 | 1 |
| 312745 | quetiapine (as quetiapine fumarate) 300 MG Oral Tablet | SY | 448cbd68-ab4f-447c-8e47-0f874fb5bcb4 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 60429-416-01 | 60429041601 | 100 TABLET, FILM COATED in 1 BOTTLE (60429-416-01) | 2015-07-01 | 0000-00-00 | No | No | Current |