carbamazepine 200 MG 12 HR Extended Release Oral Tablet
- RxCUI
- 402505
- RxNorm name
- carbamazepine 200 MG 12 HR Extended Release Oral Tablet
- Display name
- carbamazepine 200 MG 12 HR Extended Release Oral Tablet
- Full name
- carbamazepine 200 MG 12 HR Extended Release Oral Tablet
- Term type
- SY
- Status
- DailyMed mapping
- Updated
- 2026-06-04 23:39:08
UNII Substances#
No records found.
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 |
|---|---|---|---|---|---|---|
| CARBAMAZEPINE | CARBAMAZEPINE | American Health Packaging | 7108d630-89bc-4815-b6fb-a1f4676c496e | 2026-07-24 | Boxed warning, Warnings, Adverse reactions | 402505 |
| Tegretol | CARBAMAZEPINE | Novartis Pharmaceuticals Corporation | 8d409411-aa9f-4f3a-a52c-fbcb0c3ec053 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | 402505 |
| Carbamazepine | CARBAMAZEPINE | Ajanta Pharma USA Inc. | 2e3c4854-89a1-4e3f-88d4-e164829585fb | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | 402505 |
| Carbamazepine | CARBAMAZEPINE | Umedica Laboratories USA Inc. | 48080efd-1781-4585-83f8-c43957ac63b3 | 2026-05-26 | Boxed warning, Warnings, Adverse reactions | 402505 |
| Carbamazepine ER | CARBAMAZEPINE | Oryza Pharmaceuticals Inc. | 34b375d0-68b0-4bd5-8ac9-be043b57e91c | 2026-05-14 | Boxed warning, Warnings, Adverse reactions | 402505 |
| carbamazepine | CARBAMAZEPINE | Zydus Lifesciences Limited | d10e5f83-56db-4bc9-8c51-150a2e3e20ea | 2026-05-05 | Boxed warning, Warnings, Adverse reactions | 402505 |
| carbamazepine | CARBAMAZEPINE | Zydus Pharmaceuticals (USA) Inc. | c5e4a25a-0137-4327-96f5-15735891ad5c | 2026-05-05 | Boxed warning, Warnings, Adverse reactions | 402505 |
| CARBAMAZEPINE ER | CARBAMAZEPINE | Bostal LLC | b48741b3-0889-47b8-a26e-b12614f6e7fc | 2026-04-29 | Boxed warning, Warnings, Adverse reactions | 402505 |
| Carbamazepine | CARBAMAZEPINE | REMEDYREPACK INC. | 20cd4276-afb1-43e5-abb3-e2af7f8a71dd | 2026-04-15 | Boxed warning, Warnings, Adverse reactions | 402505 |
| Carbamazepine | CARBAMAZEPINE | Torrent Pharmaceuticals Limited | 7c4860c1-daba-4e0f-97fd-d30cbc8603a2 | 2026-03-03 | Boxed warning, Warnings, Adverse reactions | 402505 |
| Carbamazepine | CARBAMAZEPINE | Northstar Rx LLC | b563e4a1-d7dd-4901-ad45-614f85687589 | 2026-02-26 | Boxed warning, Warnings, Adverse reactions | 402505 |
| Carbamazepine | CARBAMAZEPINE | Jubilant Cadista Pharmaceuticals Inc. | 7c1dd8ce-c490-40b4-b17a-da331df24cba | 2026-02-19 | Boxed warning, Warnings, Adverse reactions | 402505 |
| Carbamazepine | CARBAMAZEPINE | Golden State Medical Supply, Inc. | 1922a7cd-6a43-dab5-e063-6294a90a3d8f | 2026-02-18 | Boxed warning, Warnings, Adverse reactions | 402505 |
| Carbamazepine | CARBAMAZEPINE | Sun Pharmaceutical Industries, Inc. | 0526a054-3eda-49b4-b390-7d5d16e30af8 | 2026-01-22 | Boxed warning, Warnings, Adverse reactions | 402505 |
| Carbamazepine ER | CARBAMAZEPINE | Epic Pharma, LLC | 46a9771e-5830-4905-b5fc-5d1c61fd56a0 | 2026-01-15 | Boxed warning, Warnings, Adverse reactions | 402505 |
| CARBAMAZEPINE | CARBAMAZEPINE | Rising Pharma Holdings, Inc. | bf1590a0-68a7-45ed-817e-f97366f96ec4 | 2025-12-17 | Boxed warning, Warnings, Adverse reactions | 402505 |
| Carbamazepine ER | CARBAMAZEPINE ER | Chartwell RX, LLC | bf2bff52-d1ae-4b81-951c-7d39d3c5058f | 2025-12-09 | Boxed warning, Warnings, Adverse reactions | 402505 |
| Carbamazepine | CARBAMAZEPINE | Ascend Laboratories, LLC | f0a254c5-bd33-4b14-b9f0-830b3438f5c6 | 2025-11-03 | Boxed warning, Warnings, Adverse reactions | 402505 |
| Carbamazepine | CARBAMAZEPINE | Alembic Pharmaceuticals Inc. | 726a127b-03b2-44e8-a63d-078b35e27525 | 2025-10-31 | Boxed warning, Warnings, Adverse reactions | 402505 |
| carbamazepine | CARBAMAZEPINE | Northstar Rx LLC | c91a5a1b-5481-445b-86e8-f10109ac3937 | 2025-10-28 | Boxed warning, Warnings, Adverse reactions | 402505 |
DailyMed RxNorm Mappings#
| Set ID | RxNorm string | TTY | SPL version | Label | Effective |
|---|---|---|---|---|---|
| 8d409411-aa9f-4f3a-a52c-fbcb0c3ec053 | carbamazepine 200 MG 12 HR Extended Release Oral Tablet | SY | 36 | Tegretol | 20251216 |
| 8d409411-aa9f-4f3a-a52c-fbcb0c3ec053 | carBAMazepine 200 MG 12HR Extended Release Oral Tablet | PSN | 36 | Tegretol | 20251216 |
| 8d409411-aa9f-4f3a-a52c-fbcb0c3ec053 | 12 HR carbamazepine 200 MG Extended Release Oral Tablet | SCD | 36 | Tegretol | 20251216 |
| 7c1dd8ce-c490-40b4-b17a-da331df24cba | 12 HR carbamazepine 200 MG Extended Release Oral Tablet | SCD | 12 | Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg and 400 mg | 20260219 |
| 7c1dd8ce-c490-40b4-b17a-da331df24cba | carbamazepine 200 MG 12 HR Extended Release Oral Tablet | SY | 12 | Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg and 400 mg | 20260219 |
| 7c1dd8ce-c490-40b4-b17a-da331df24cba | carBAMazepine 200 MG 12HR Extended Release Oral Tablet | PSN | 12 | Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg and 400 mg | 20260219 |
| 0526a054-3eda-49b4-b390-7d5d16e30af8 | carBAMazepine 200 MG 12HR Extended Release Oral Tablet | PSN | 11 | Carbamazepine Tablets USP, (Chewable), 100 mg and 200 mg Carbamazepine Tablets USP, 200 mg Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg Carbamazepine Oral Suspension USP, 100 mg/5 mL | 20260122 |
| 0526a054-3eda-49b4-b390-7d5d16e30af8 | 12 HR carbamazepine 200 MG Extended Release Oral Tablet | SCD | 11 | Carbamazepine Tablets USP, (Chewable), 100 mg and 200 mg Carbamazepine Tablets USP, 200 mg Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg Carbamazepine Oral Suspension USP, 100 mg/5 mL | 20260122 |
| 0526a054-3eda-49b4-b390-7d5d16e30af8 | carbamazepine 200 MG 12 HR Extended Release Oral Tablet | SY | 11 | Carbamazepine Tablets USP, (Chewable), 100 mg and 200 mg Carbamazepine Tablets USP, 200 mg Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg Carbamazepine Oral Suspension USP, 100 mg/5 mL | 20260122 |
| b48741b3-0889-47b8-a26e-b12614f6e7fc | carBAMazepine 200 MG 12HR Extended Release Oral Tablet | PSN | 9 | Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg, 400 mg Rx only Prescribing Information | 20260429 |
| b48741b3-0889-47b8-a26e-b12614f6e7fc | carbamazepine 200 MG 12 HR Extended Release Oral Tablet | SY | 9 | Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg, 400 mg Rx only Prescribing Information | 20260429 |
| b48741b3-0889-47b8-a26e-b12614f6e7fc | 12 HR carbamazepine 200 MG Extended Release Oral Tablet | SCD | 9 | Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg, 400 mg Rx only Prescribing Information | 20260429 |
| c5e4a25a-0137-4327-96f5-15735891ad5c | carbamazepine 200 MG 12 HR Extended Release Oral Tablet | SY | 7 | Carbamazepine Extended-release Tablets, USP Rx only | 20260505 |
| c5e4a25a-0137-4327-96f5-15735891ad5c | 12 HR carbamazepine 200 MG Extended Release Oral Tablet | SCD | 7 | Carbamazepine Extended-release Tablets, USP Rx only | 20260505 |
| c5e4a25a-0137-4327-96f5-15735891ad5c | carBAMazepine 200 MG 12HR Extended Release Oral Tablet | PSN | 7 | Carbamazepine Extended-release Tablets, USP Rx only | 20260505 |
| d10e5f83-56db-4bc9-8c51-150a2e3e20ea | 12 HR carbamazepine 200 MG Extended Release Oral Tablet | SCD | 7 | Carbamazepine Extended-release Tablets, USP Rx only | 20260505 |
| d10e5f83-56db-4bc9-8c51-150a2e3e20ea | carbamazepine 200 MG 12 HR Extended Release Oral Tablet | SY | 7 | Carbamazepine Extended-release Tablets, USP Rx only | 20260505 |
| d10e5f83-56db-4bc9-8c51-150a2e3e20ea | carBAMazepine 200 MG 12HR Extended Release Oral Tablet | PSN | 7 | Carbamazepine Extended-release Tablets, USP Rx only | 20260505 |
| 7c4860c1-daba-4e0f-97fd-d30cbc8603a2 | carBAMazepine 200 MG 12HR Extended Release Oral Tablet | PSN | 7 | Carbamazepine extended-release tablets, USP 100 mg, 200 mg, 400 mg Rx only Prescribing Information | 20260303 |
| 7c4860c1-daba-4e0f-97fd-d30cbc8603a2 | 12 HR carbamazepine 200 MG Extended Release Oral Tablet | SCD | 7 | Carbamazepine extended-release tablets, USP 100 mg, 200 mg, 400 mg Rx only Prescribing Information | 20260303 |
| 7c4860c1-daba-4e0f-97fd-d30cbc8603a2 | carbamazepine 200 MG 12 HR Extended Release Oral Tablet | SY | 7 | Carbamazepine extended-release tablets, USP 100 mg, 200 mg, 400 mg Rx only Prescribing Information | 20260303 |
| de67de85-15b3-4c27-b604-d028ce3789d0 | carbamazepine 200 MG 12 HR Extended Release Oral Tablet | SY | 7 | Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg, 400 mg Rx only | 20251023 |
| de67de85-15b3-4c27-b604-d028ce3789d0 | carBAMazepine 200 MG 12HR Extended Release Oral Tablet | PSN | 7 | Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg, 400 mg Rx only | 20251023 |
| de67de85-15b3-4c27-b604-d028ce3789d0 | 12 HR carbamazepine 200 MG Extended Release Oral Tablet | SCD | 7 | Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg, 400 mg Rx only | 20251023 |
| 48080efd-1781-4585-83f8-c43957ac63b3 | 12 HR carbamazepine 200 MG Extended Release Oral Tablet | SCD | 6 | Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg and 400 mg | 20260526 |
| 48080efd-1781-4585-83f8-c43957ac63b3 | carbamazepine 200 MG 12 HR Extended Release Oral Tablet | SY | 6 | Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg and 400 mg | 20260526 |
| 48080efd-1781-4585-83f8-c43957ac63b3 | carBAMazepine 200 MG 12HR Extended Release Oral Tablet | PSN | 6 | Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg and 400 mg | 20260526 |
| 20cd4276-afb1-43e5-abb3-e2af7f8a71dd | carbamazepine 200 MG 12 HR Extended Release Oral Tablet | SY | 5 | Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg and 400 mg | 20260415 |
| 20cd4276-afb1-43e5-abb3-e2af7f8a71dd | carBAMazepine 200 MG 12HR Extended Release Oral Tablet | PSN | 5 | Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg and 400 mg | 20260415 |
| 20cd4276-afb1-43e5-abb3-e2af7f8a71dd | 12 HR carbamazepine 200 MG Extended Release Oral Tablet | SCD | 5 | Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg and 400 mg | 20260415 |
| f0a254c5-bd33-4b14-b9f0-830b3438f5c6 | carbamazepine 200 MG 12 HR Extended Release Oral Tablet | SY | 5 | Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg and 400 mg Rx only Prescribing Information | 20251103 |
| f0a254c5-bd33-4b14-b9f0-830b3438f5c6 | 12 HR carbamazepine 200 MG Extended Release Oral Tablet | SCD | 5 | Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg and 400 mg Rx only Prescribing Information | 20251103 |
| f0a254c5-bd33-4b14-b9f0-830b3438f5c6 | carBAMazepine 200 MG 12HR Extended Release Oral Tablet | PSN | 5 | Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg and 400 mg Rx only Prescribing Information | 20251103 |
| 726a127b-03b2-44e8-a63d-078b35e27525 | carBAMazepine 200 MG 12HR Extended Release Oral Tablet | PSN | 5 | Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg, 400 mg Rx only Prescribing Information | 20251031 |
| 726a127b-03b2-44e8-a63d-078b35e27525 | carbamazepine 200 MG 12 HR Extended Release Oral Tablet | SY | 5 | Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg, 400 mg Rx only Prescribing Information | 20251031 |
| 726a127b-03b2-44e8-a63d-078b35e27525 | 12 HR carbamazepine 200 MG Extended Release Oral Tablet | SCD | 5 | Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg, 400 mg Rx only Prescribing Information | 20251031 |
| c91a5a1b-5481-445b-86e8-f10109ac3937 | carbamazepine 200 MG 12 HR Extended Release Oral Tablet | SY | 5 | Carbamazepine Extended-release Tablets, USP Rx only Prescribing Information | 20251028 |
| c91a5a1b-5481-445b-86e8-f10109ac3937 | carBAMazepine 200 MG 12HR Extended Release Oral Tablet | PSN | 5 | Carbamazepine Extended-release Tablets, USP Rx only Prescribing Information | 20251028 |
| c91a5a1b-5481-445b-86e8-f10109ac3937 | 12 HR carbamazepine 200 MG Extended Release Oral Tablet | SCD | 5 | Carbamazepine Extended-release Tablets, USP Rx only Prescribing Information | 20251028 |
| bf1590a0-68a7-45ed-817e-f97366f96ec4 | 12 HR carbamazepine 200 MG Extended Release Oral Tablet | SCD | 5 | Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg, 400 mg Rx only Prescribing Information | 20250410 |
| bf1590a0-68a7-45ed-817e-f97366f96ec4 | carBAMazepine 200 MG 12HR Extended Release Oral Tablet | PSN | 5 | Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg, 400 mg Rx only Prescribing Information | 20250410 |
| bf1590a0-68a7-45ed-817e-f97366f96ec4 | carbamazepine 200 MG 12 HR Extended Release Oral Tablet | SY | 5 | Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg, 400 mg Rx only Prescribing Information | 20250410 |
| 1922a7cd-6a43-dab5-e063-6294a90a3d8f | carbamazepine 200 MG 12 HR Extended Release Oral Tablet | SY | 4 | Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg | 20260218 |
| 1922a7cd-6a43-dab5-e063-6294a90a3d8f | carBAMazepine 200 MG 12HR Extended Release Oral Tablet | PSN | 4 | Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg | 20260218 |
| 1922a7cd-6a43-dab5-e063-6294a90a3d8f | 12 HR carbamazepine 200 MG Extended Release Oral Tablet | SCD | 4 | Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg | 20260218 |
| 46a9771e-5830-4905-b5fc-5d1c61fd56a0 | carBAMazepine 200 MG 12HR Extended Release Oral Tablet | PSN | 3 | Carbamazepine Extended-Release Tablets, USP | 20260115 |
| 46a9771e-5830-4905-b5fc-5d1c61fd56a0 | 12 HR carbamazepine 200 MG Extended Release Oral Tablet | SCD | 3 | Carbamazepine Extended-Release Tablets, USP | 20260115 |
| 46a9771e-5830-4905-b5fc-5d1c61fd56a0 | carbamazepine 200 MG 12 HR Extended Release Oral Tablet | SY | 3 | Carbamazepine Extended-Release Tablets, USP | 20260115 |
| 7108d630-89bc-4815-b6fb-a1f4676c496e | carBAMazepine 200 MG 12HR Extended Release Oral Tablet | PSN | 3 | Carbamazepine Extended-Release Tablets, USP 8458321/0325 Rx only Prescribing Information | 20250423 |
| 7108d630-89bc-4815-b6fb-a1f4676c496e | carbamazepine 200 MG 12 HR Extended Release Oral Tablet | SY | 3 | Carbamazepine Extended-Release Tablets, USP 8458321/0325 Rx only Prescribing Information | 20250423 |
| 7108d630-89bc-4815-b6fb-a1f4676c496e | 12 HR carbamazepine 200 MG Extended Release Oral Tablet | SCD | 3 | Carbamazepine Extended-Release Tablets, USP 8458321/0325 Rx only Prescribing Information | 20250423 |
| 282c954f-e34a-4bd5-b5eb-771e3c56936f | carbamazepine 200 MG 12 HR Extended Release Oral Tablet | SY | 3 | Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg, 400 mg | 20231019 |
| 282c954f-e34a-4bd5-b5eb-771e3c56936f | carBAMazepine 200 MG 12HR Extended Release Oral Tablet | PSN | 3 | Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg, 400 mg | 20231019 |
| 282c954f-e34a-4bd5-b5eb-771e3c56936f | 12 HR carbamazepine 200 MG Extended Release Oral Tablet | SCD | 3 | Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg, 400 mg | 20231019 |
| bf2bff52-d1ae-4b81-951c-7d39d3c5058f | carbamazepine 200 MG 12 HR Extended Release Oral Tablet | SY | 2 | Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg, 400 mg Rx only Prescribing Information | 20251209 |
| bf2bff52-d1ae-4b81-951c-7d39d3c5058f | 12 HR carbamazepine 200 MG Extended Release Oral Tablet | SCD | 2 | Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg, 400 mg Rx only Prescribing Information | 20251209 |
| bf2bff52-d1ae-4b81-951c-7d39d3c5058f | carBAMazepine 200 MG 12HR Extended Release Oral Tablet | PSN | 2 | Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg, 400 mg Rx only Prescribing Information | 20251209 |
| 2e3c4854-89a1-4e3f-88d4-e164829585fb | carBAMazepine 200 MG 12HR Extended Release Oral Tablet | PSN | 2 | Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg, 400 mg Rx only Prescribing Information | 20240123 |
| 2e3c4854-89a1-4e3f-88d4-e164829585fb | 12 HR carbamazepine 200 MG Extended Release Oral Tablet | SCD | 2 | Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg, 400 mg Rx only Prescribing Information | 20240123 |
| 2e3c4854-89a1-4e3f-88d4-e164829585fb | carbamazepine 200 MG 12 HR Extended Release Oral Tablet | SY | 2 | Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg, 400 mg Rx only Prescribing Information | 20240123 |
| 34b375d0-68b0-4bd5-8ac9-be043b57e91c | carBAMazepine 200 MG 12HR Extended Release Oral Tablet | PSN | 1 | Carbamazepine Extended-Release Tablets, USP | 20260514 |
| 34b375d0-68b0-4bd5-8ac9-be043b57e91c | carbamazepine 200 MG 12 HR Extended Release Oral Tablet | SY | 1 | Carbamazepine Extended-Release Tablets, USP | 20260514 |
| 34b375d0-68b0-4bd5-8ac9-be043b57e91c | 12 HR carbamazepine 200 MG Extended Release Oral Tablet | SCD | 1 | Carbamazepine Extended-Release Tablets, USP | 20260514 |
| b563e4a1-d7dd-4901-ad45-614f85687589 | 12 HR carbamazepine 200 MG Extended Release Oral Tablet | SCD | 1 | Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg and 400 mg | 20260226 |
| b563e4a1-d7dd-4901-ad45-614f85687589 | carBAMazepine 200 MG 12HR Extended Release Oral Tablet | PSN | 1 | Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg and 400 mg | 20260226 |
| b563e4a1-d7dd-4901-ad45-614f85687589 | carbamazepine 200 MG 12 HR Extended Release Oral Tablet | SY | 1 | Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg and 400 mg | 20260226 |
| 1fc170d7-db1a-486d-8c10-faa6e3da3b1e | carbamazepine 200 MG 12 HR Extended Release Oral Tablet | SY | 1 | Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg, 400 mg Rx only Prescribing Information | 20250726 |
| 1fc170d7-db1a-486d-8c10-faa6e3da3b1e | carBAMazepine 200 MG 12HR Extended Release Oral Tablet | PSN | 1 | Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg, 400 mg Rx only Prescribing Information | 20250726 |
| 1fc170d7-db1a-486d-8c10-faa6e3da3b1e | 12 HR carbamazepine 200 MG Extended Release Oral Tablet | SCD | 1 | Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg, 400 mg Rx only Prescribing Information | 20250726 |