Quetiapine fumarate
- Product NDC
- 71335-1362
- 11-digit product format
- 713351362
- Labeler code
- 71335
- Product ID
- 71335-1362_0a8804e2-28c3-4f92-bf7a-c26c8d00cc71
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA203359
- Marketing category
- ANDA
- Marketing start
- 2016-06-14
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Quetiapine fumarate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| QUETIAPINE FUMARATE | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2S3PL1B6UJ |
| Rxcui | 317174 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 71335-1362-1 | 2024-05-20 | C162847 | 48780-1 | 1030e365-2ada-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997 |
| 71335-1362-2 | 2024-05-20 | C162847 | 48780-1 | 1030e365-2ada-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997 |
| 71335-1362-3 | 2024-05-20 | C162847 | 48780-1 | 1030e365-2ada-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997 |
| 71335-1362-4 | 2024-05-20 | C162847 | 48780-1 | 1030e365-2ada-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997 |
| 71335-1362-5 | 2024-05-20 | C162847 | 48780-1 | 1030e365-2ada-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997 |
| 71335-1362-1 | 2024-01-30 | C162847 | 48780-1 | 1030e365-2ada-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997 |
| 71335-1362-2 | 2024-01-30 | C162847 | 48780-1 | 1030e365-2ada-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997 |
| 71335-1362-3 | 2024-01-30 | C162847 | 48780-1 | 1030e365-2ada-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997 |
| 71335-1362-4 | 2024-01-30 | C162847 | 48780-1 | 1030e365-2ada-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997 |
| 71335-1362-5 | 2024-01-30 | C162847 | 48780-1 | 1030e365-2ada-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use QUETIAPINE TABLETS safely and effectively. See full prescribing information for QUETIAPINE TABLETS. QUETIAPINE tablets, for oral use Initial U.S. Approval: 1997 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-1362-1 | Quetiapine fumarate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
| 71335-1362-2 | Quetiapine fumarate | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 4 |
| 71335-1362-3 | Quetiapine fumarate | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 4 |
| 71335-1362-4 | Quetiapine fumarate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 4 |
| 71335-1362-5 | Quetiapine fumarate | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-1362 | QUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 4 | Current NDC, Legacy NDC, 5 package rows | 20240522_293a9857-d138-4583-abc9-35b75660e324.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71335-1362-1 | 71335136201 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1362-1) | 2019-10-03 | 0000-00-00 | No | No | Current |
| 71335-1362-2 | 71335136202 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1362-2) | 2024-05-20 | 0000-00-00 | No | No | Current |
| 71335-1362-3 | 71335136203 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1362-3) | 2024-05-20 | 0000-00-00 | No | No | Current |
| 71335-1362-4 | 71335136204 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1362-4) | 2024-05-20 | 0000-00-00 | No | No | Current |
| 71335-1362-5 | 71335136205 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1362-5) | 2024-05-20 | 0000-00-00 | No | No | Current |