SEROQUEL
- Product NDC
- 69189-0484
- 11-digit product format
- 691890484
- Labeler code
- 69189
- Product ID
- 69189-0484_adff3967-150b-47c7-b047-03458ee7a47d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine fumarate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Avera McKennan Hospital
- Application
- NDA022047
- Marketing category
- NDA
- Marketing start
- 2016-01-13
- Marketing end
- 0000-00-00
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 300 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- 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 |
|---|---|---|---|---|---|
| 69189-0484-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-d2f5-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use SEROQUEL XR safely and effectively. See full prescribing information for SEROQUEL XR. SEROQUEL XR ® (quetiapine fumarate) extended-release tablets, for oral use Initial U.S. Approval: 1997 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69189-0484-1 | SEROQUELXR | 1 in 1 DOSE PACK | TABLET, EXTENDED RELEASE | 1 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69189-0484 | SEROQUEL XR (QUETIAPINE FUMARATE) TABLET, EXTENDED RELEASE [AVERA MCKENNAN HOSPITAL] | 1 | Legacy NDC, 1 package rows | 20170414_63cf6e35-4d68-4316-8579-823419f386de.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 721794 | QUEtiapine fumarate 300 MG 24HR Extended Release Oral Tablet | PSN | 63cf6e35-4d68-4316-8579-823419f386de | 1 |
| 721795 | SEROQUEL XR 300 MG 24HR Extended Release Oral Tablet | PSN | 63cf6e35-4d68-4316-8579-823419f386de | 1 |
| 721795 | 24 HR quetiapine 300 MG Extended Release Oral Tablet [Seroquel] | SBD | 63cf6e35-4d68-4316-8579-823419f386de | 1 |
| 721794 | 24 HR quetiapine 300 MG Extended Release Oral Tablet | SCD | 63cf6e35-4d68-4316-8579-823419f386de | 1 |
| 721795 | 24 HR Seroquel 300 MG Extended Release Oral Tablet | SY | 63cf6e35-4d68-4316-8579-823419f386de | 1 |
| 721794 | quetiapine 300 MG (as quetiapine fumarate 345 MG) 24 HR Extended Release Oral Tablet | SY | 63cf6e35-4d68-4316-8579-823419f386de | 1 |
| 721794 | quetiapine 300 MG 24 HR Extended Release Oral Tablet | SY | 63cf6e35-4d68-4316-8579-823419f386de | 1 |
| 721795 | Seroquel XR 300 MG (quetiapine fumarate 345 MG) 24 HR Extended Release Oral Tablet | SY | 63cf6e35-4d68-4316-8579-823419f386de | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 69189-0484-1 | 69189048401 | 1 in 1 DOSE PACK | Historical |