quetiapine fumarate
- Product NDC
- 43353-150
- 11-digit product format
- 433530150
- Labeler code
- 43353
- Product ID
- 43353-150_8b6810b1-c1d9-499e-82b9-95e6e30dd8e8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- quetiapine fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA090960
- Marketing category
- ANDA
- Marketing start
- 2015-07-21
- Marketing end
- 0000-00-00
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 300 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 43353-150-53 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e1b5-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use QUETIAPINE TABLETS, USP safely and effectively. See full prescribing information for QUETIAPINE TABLETS, USP. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43353-150-53 | quetiapine fumarate | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43353-150-53 | EA - Each | 43353-150 | afcaea1e-0403-47ff-b46e-4fffd3663a0a | 1 | 2016-07-19 |
DailyMed Dashboard NDC Coverage#
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 | Status |
|---|---|---|---|
| 43353-150-53 | 43353015053 | 60 in 1 BOTTLE | Historical |