Quetiapine fumarate
- Product NDC
- 47335-906
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA201190
- Marketing category
- ANDA
- Substance
- QUETIAPINE FUMARATE
- Current FDA listing
- Yes
Packages
| Package NDC | Description | Marketing start | Marketing end | Sample | Status |
|---|
| 47335-906-18 | 1000 TABLET, FILM COATED in 1 BOTTLE (47335-906-18) | 20120328 | | No | Historical |
| 47335-906-61 | 10 BLISTER PACK in 1 BOX, UNIT-DOSE (47335-906-61) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 20120328 | | No | Historical |
| 47335-906-83 | 30 TABLET, FILM COATED in 1 BOTTLE (47335-906-83) | 20120328 | | No | Historical |
| 47335-906-86 | 60 TABLET, FILM COATED in 1 BOTTLE (47335-906-86) | 20120328 | | No | Historical |
| 47335-906-88 | 100 TABLET, FILM COATED in 1 BOTTLE (47335-906-88) | 20120328 | | No | Historical |
Related DailyMed Labels
| Set ID | Title | Manufacturer | Effective date | Type | Version |
|---|
| 9a024071-e620-48e8-9f22-d4cda5dc5ab1 | 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 | Bryant Ranch Prepack | 2025-04-24 | HUMAN PRESCRIPTION DRUG LABEL | 7 |
| ffe52b98-9872-48c1-90fd-8fcd37c3432f | 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 | Sun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited | 2025-03-03 | Human Prescription Drug Label | 23 |
| dfb4820d-d34f-2ddf-e053-2a95a90a9c21 | 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 | NuCare Pharmaceuticals,Inc. | 2022-05-23 | HUMAN PRESCRIPTION DRUG LABEL | 1 |