FDA labels
Search the openFDA drug-label export by label identifier, NDC, application, RxCUI, UNII, product name, or manufacturer.
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report.
Label matches#
| Label | Generic name | Manufacturer | SPL set ID | Effective date | Safety fields | Match |
|---|---|---|---|---|---|---|
| captopril | CAPTOPRIL | AMICI PHARMA, INC. | 1395ba5b-2fc9-41ff-9c43-e0740d781dee | 2026-09-14 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| ROFLUMILAST | ROFLUMILAST | Amici Pharma Inc. | cb3781ff-5350-4f9a-b247-0b04eb0f2b92 | 2026-09-01 | Warnings, Adverse reactions | Name/manufacturer search |
| Amphetamine Sulfate | AMPHETAMINE SULFATE | Amici Pharma, Inc. | e045dc28-e05d-4407-9d44-d0a11ca558e6 | 2026-07-21 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Bupropion Hydrochloride | BUPROPION HYDROCHLORIDE | Amici Pharma, Inc. | fbb587fa-75c0-4f4d-8eaf-f0e7ba8b5c75 | 2026-05-21 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Terazosin Hydrochloride | TERAZOSIN HYDROCHLORIDE | Amici Pharma, Inc. | 4007dbd3-e850-43e7-8a56-8735e31063cd | 2026-05-20 | Warnings, Adverse reactions | Name/manufacturer search |
| Gabapentin | GABAPENTIN | Amici Pharma, Inc. | 1ea83c18-7107-41f4-8305-62725c1c45c8 | 2026-05-19 | Warnings, Adverse reactions | Name/manufacturer search |
| Pravastatin Sodium | PRAVASTATIN SODIUM | Amici Pharma, Inc. | e6551230-fe4c-4a6e-9c19-ae9945b76db0 | 2026-05-19 | Warnings, Adverse reactions | Name/manufacturer search |
| Flurbiprofen Sodium | FLURBIPROFEN SODIUM | Amici Pharma, Inc. | c27f2d57-4b9d-4b78-8d85-3bac84f733b1 | 2026-04-14 | Warnings, Adverse reactions | Name/manufacturer search |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Amici Pharma, Inc. | fb12459c-82f8-43d2-8c05-a4b6d4a3e948 | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Metolazone | METOLAZONE | Amici Pharma, Inc | cbfa3d5c-cce9-4afa-b064-06f1e1041eac | 2026-04-01 | Warnings, Adverse reactions | Name/manufacturer search |
| Risperidone | RISPERIDONE | Amici Pharma, Inc. | ca41c144-224a-4d57-88d7-8778e6c69ed2 | 2026-03-26 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| BUTALBITAL AND ACETAMINOPHEN | BUTALBITAL AND ACETAMINOPHEN | Amici Pharma, Inc. | 3280501f-928a-4112-803d-fb9771c86547 | 2026-03-17 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| TERBINAFINE HYDROCHLORIDE | TERBINAFINE TABLETS 250 MG | Amici Pharma, Inc. | dd8724e9-bef9-4258-b536-9c6d872c3bf8 | 2026-02-18 | Warnings, Adverse reactions | Name/manufacturer search |
| NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | Amici Pharma Inc | edda985c-004e-4487-b856-13cf2cdb900f | 2026-01-08 | Warnings, Adverse reactions | Name/manufacturer search |
| ketorolac tromethamine | KETOROLAC TROMETHAMINE | Amici Pharma Inc. | 8b26240c-b72b-42a6-ab33-a1e38224fbe0 | 2025-12-10 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Digoxin | DIGOXIN | Amici Pharma, Inc | eda7193a-e139-41d5-a11b-dc6241645995 | 2025-10-31 | Warnings, Adverse reactions | Name/manufacturer search |
| DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM, FILM COATED | Amici Pharma, Inc | c4ce1497-9cb1-4632-b1a2-4f61043c018d | 2025-08-22 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Ketoconazole | KETOCONAZOLE | Amici Pharma Inc. | 369f31da-d3c3-49b8-956f-f70598760164 | 2025-06-21 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Diclofenac Potassium | DICLOFENAC POTASSIUM | Amici Pharma Inc. | f2908870-a517-491f-8771-4100d11b4b64 | 2025-06-02 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| metronidazole | METRONIDAZOLE | AMICI PHARMA INC | 9f1fec88-097f-42b9-a36f-214648d7eebb | 2025-04-02 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| metronidazole | METRONIDAZOLE | AMICI PHARMA INC | 4920fcf7-5ceb-46e9-82e0-dc508900bb91 | 2025-04-02 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |