NDC 80425-0413-01 - 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
- 80425-0413
- Requested NDC
- 80425-0413-01
- Package NDCs from labels
- 80425-0413-1, 80425-0413-3, 80425-0413-2, 80425-0413-01
- Manufacturer
- Advanced Rx of Tennessee, LLC
- Effective date
- 2024-07-11
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Quetiapine fumarate - Advanced Rx of Tennessee, LLC | Advanced Rx of Tennessee, LLC | 2024-07-11 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80425-0413-1 | Quetiapine fumarate | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 80425-0413-2 | Quetiapine fumarate | 60 in 1 BOTTLE | TABLET | 60 | 1 | |
| 80425-0413-3 | Quetiapine fumarate | 90 in 1 BOTTLE | TABLET | 90 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0413 | QUETIAPINE FUMARATE TABLET [ADVANCED RX OF TENNESSEE, LLC] | 1 | Current NDC, 3 package rows | 20240712_1cfc847b-0d8d-fc94-e063-6394a90a311f.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0413-1 | EA - Each | 80425-0413 | b2c253ba-9ec4-455e-bb39-dbb03640fca6 | 1 | 2024-08-12 |
| 80425-0413-2 | EA - Each | 80425-0413 | 5753aa80-8877-41e2-b605-01f83f3a5d9b | 1 | 2024-08-12 |
| 80425-0413-3 | EA - Each | 80425-0413 | 6a9dd31f-d9cf-4b21-9113-c392ebd264dd | 1 | 2024-08-12 |
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 |
|---|---|---|---|---|---|---|
| VEIRFOO Brightening Hydrating Antiwrinkle Sunscreen | TITANIUM DIOXIDE, OCTINOXATE | LCM TECHNOLOGY Co., Ltd | 4cbbf8aa-8910-b7e7-e063-6294a90a4f07 | 2026-08-07 | Warnings | 15FIX9V2JP |
| Quetiapine | QUETIAPINE | Ascend Laboratories, LLC | 3112a006-1c61-47f2-84f5-9a7670d09c9b | 2026-08-06 | Boxed warning, Warnings, Adverse reactions | 317174 312745 616483 312744 616487 312743 2S3PL1B6UJ |
| EltaMD UV Restore | TITANIUM DIOXIDE, ZINC OXIDE SUNSCREEN | CP Skin Health Group, Inc | 37fee381-ce6b-4949-9a4a-778aa839fb84 | 2026-08-06 | Warnings | 15FIX9V2JP |
| Leader Lubricant Eye Drops 30ct | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL | CARDINAL HEALTH 110, LLC. DBA LEADER | 8df69f2c-40c4-245c-e053-2a95a90a5406 | 2026-08-05 | Warnings | B697894SGQ |
| Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEY | OCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8% | Lale Cosmetics LLC | 581fb0cd-c55d-d562-e063-6394a90a7f11 | 2026-08-03 | Warnings | 15FIX9V2JP |
| EltaMD UV Active | ZINC OXIDE AND TITANIUM DIOXIDE SUNSCREEN | CP Skin Health Group, Inc | 39d16479-d491-4c19-aa11-674461687c7b | 2026-08-03 | Warnings | 15FIX9V2JP |
| Continuous Correction Cream | TITANIUM DIOXIDE | Baxter of California, LLC | 1cbcc648-f2e1-af60-e063-6294a90ad4bb | 2026-07-31 | Warnings | 15FIX9V2JP |
| Cover Creme | TITANIUM DIOXIDE | Baxter of California | 31f5e8c4-523f-4596-e063-6294a90a6a12 | 2026-07-31 | Warnings | 15FIX9V2JP |
| 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 616483 2S3PL1B6UJ |
| ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-C | OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE | BEL STAR S.A. | 575fb2c3-e332-8a3b-e063-6394a90a9fd9 | 2026-07-24 | Warnings | 15FIX9V2JP |
| 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 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.