NDC 67046-0637-03 - Quetiapine fumarate
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 67046-0637
- Requested NDC
- 67046-0637-03
- Package NDCs from labels
- 67046-0637-3, 67046-0637-03
- Manufacturer
- Coupler LLC
- Effective date
- 2026-05-26
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Quetiapine fumarate - Coupler LLC | Coupler LLC | 2026-05-26 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67046-0637-3 | Quetiapine fumarate | 30 in 1 BLISTER PACK | TABLET | 30 | 1 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Quetiapine fumarate | QUETIAPINE FUMARATE | REMEDYREPACK INC. | c6c454c4-3eae-48ae-bf17-5dccdb659141 | 2026-07-30 | Boxed warning, Warnings, Adverse reactions | ANDA201109 616487 2S3PL1B6UJ |
| Quetiapine fumarate | QUETIAPINE FUMARATE | REMEDYREPACK INC. | d38f0f4e-dc0f-4c92-a212-c4da3db74801 | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | ANDA201109 2S3PL1B6UJ |
| True Coast SPF 50 Mineral Sunscreen | ZINC OXIDE 18%, TITANIUM DIOXIDE 6% | Foshan Sugar Max Cosmetics CO.,Ltd | 5379466d-8d14-5fc2-e063-6394a90abd7e | 2026-07-22 | Warnings | 15FIX9V2JP |
| Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte Foundation | OCTINOXATE AND TITANIUM DIOXIDE | SICOS ET CIE | 571f23e9-1126-e32d-e063-6294a90a9951 | 2026-07-21 | Warnings | 15FIX9V2JP |
| MENS SPF50 ALL IN ONE SUNSCREEN | MENS SPF50 ALL IN ONE SUNSCREEN | Lance (Guangzhou) Biological Technology Co., Ltd. | 57074480-77fd-cc06-e063-6294a90a28d4 | 2026-07-20 | Warnings | 15FIX9V2JP |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | REMEDYREPACK INC. | 3085f68d-e83c-4f59-b058-8bdae7f4e537 | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | 312743 2S3PL1B6UJ |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | REMEDYREPACK INC. | b8864cb9-1c6a-4e36-9893-eb1403ee8745 | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | 312744 2S3PL1B6UJ |
| Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte Foundation | OCTINOXATE AND TITANIUM DIOXIDE | L'Oreal USA Products Inc | 5711364c-f9b4-bfa6-e063-6294a90ace4a | 2026-07-20 | Warnings | 15FIX9V2JP |
| QUETIAPINE | QUETIAPINE | REMEDYREPACK INC. | 90da6c48-3282-41dc-b4fa-75d33efa9fee | 2026-07-17 | Boxed warning, Warnings, Adverse reactions | 2S3PL1B6UJ |
| Quetiapine fumarate | QUETIAPINE FUMARATE | REMEDYREPACK INC. | ea9b9ed1-4be0-4dc0-b1dd-239caff5253e | 2026-07-17 | Boxed warning, Warnings, Adverse reactions | ANDA201109 312743 2S3PL1B6UJ |
| Quetiapine | QUETIAPINE | Major Pharmaceuticals | b02324b1-e7f0-4cbc-8778-5f7c4a5d194a | 2026-07-16 | Boxed warning, Warnings, Adverse reactions | 2S3PL1B6UJ |
| Quetiapine fumarate | QUETIAPINE FUMARATE | REMEDYREPACK INC. | 02b19885-2987-4c46-8d2a-5e59656f72e8 | 2026-07-16 | Boxed warning, Warnings, Adverse reactions | ANDA201109 317174 2S3PL1B6UJ |
| QUETIAPINE | QUETIAPINE | REMEDYREPACK INC. | 67872105-4ec6-4d46-b3b4-c672c93576d2 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | 2S3PL1B6UJ |
| Quetiapine fumarate | QUETIAPINE FUMARATE | REMEDYREPACK INC. | 695415b1-083d-4540-9f41-bde4b201f834 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | ANDA201109 312745 2S3PL1B6UJ |
| Quetiapine fumarate | QUETIAPINE FUMARATE | Bryant Ranch Prepack | c52a9bff-8a03-44f5-9128-799c7dca0467 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | 317174 2S3PL1B6UJ |
| Quetiapine fumarate | QUETIAPINE FUMARATE | Bryant Ranch Prepack | 94a81681-381e-4b3b-89ac-e86dcbe7f890 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | ANDA201109 312745 2S3PL1B6UJ |
| Quetiapine fumarate | QUETIAPINE FUMARATE | Bryant Ranch Prepack | 3eb39b4e-4c79-43b9-a30e-b4221c0e2bd2 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | 616487 2S3PL1B6UJ |
| Quetiapine fumarate | QUETIAPINE FUMARATE | Bryant Ranch Prepack | fd9cce28-0052-4b0b-8a66-a1615e082d95 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | ANDA201109 616487 2S3PL1B6UJ |
| Quetiapine fumarate | QUETIAPINE | Coupler LLC | 5643d339-50ea-405d-e063-6394a90a3b70 | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | ANDA201109 312744 2S3PL1B6UJ |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | NorthStar Rx LLC | e6e25ef9-2671-489e-8eca-58bedb4f59ab | 2026-07-09 | Boxed warning, Warnings, Adverse reactions | 317174 312745 616483 312744 616487 312743 2S3PL1B6UJ |