METHOTREXATE SODIUM - Food and Drug Administration

Set ID
d9cebc09-c68d-46f5-bdcd-fd82e945cc27
Type
Indexing - product concept
Effective date
2017-07-05
Version
1
Source
DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
LabelRelationManufacturerEffective
These highlights do not include all the information needed to use METHOTREXATE INJECTION safely and effectively. See full prescribing information for METHOTREXATE INJECTION. METHOTREXATE injection, for intravenous, intramuscular, subcutaneous, or intrathecal use Initial U.S. Approval: 1953Product nameAccord Healthcare, Inc. | Intas Pharmaceuticals Limited2026-09-04
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameA-S Medication Solutions2026-08-27
These highlights do not include all the information needed to use TREXALL ® safely and effectively. See full prescribing information for TREXALL. TREXALL ® (methotrexate tablets), for oral use Initial U.S. Approval: 1953Product nameTeva Women's Health LLC2026-06-17
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameBryant Ranch Prepack2026-06-10
These highlights do not include all the information needed to use JYLAMVO ® safely and effectively. See full prescribing information for JYLAMVO ® . JYLAMVO ® (methotrexate) oral solution Initial U.S. Approval: 1953Product nameSHORLA ONCOLOGY INC. | SHORLA PHARMA LTD. | SGS United Kingdom Limited2026-06-08
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameBryant Ranch Prepack2026-06-05
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameTeva Pharmaceuticals USA, Inc.2026-06-04
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameMajor Pharmaceuticals2026-05-28
These highlights do not include all the information needed to use XATMEP ® safely and effectively. See full prescribing information for XATMEP. XATMEP (methotrexate) oral solution Initial U.S. Approval: 1953Product nameAzurity Pharmaceuticals, Inc.2026-05-28
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameAccord Healthcare Inc. | Intas Pharmaceuticals Limited2026-05-27
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameBryant Ranch Prepack2026-05-26
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameElite Laboratories, Inc.2026-05-22
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameBryant Ranch Prepack2026-05-21
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameSun Pharmaceutical Industries, Inc. | Orion Corporation, Orion Pharma | Orion Corporation ORION PHARMA2026-05-21
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameBryant Ranch Prepack2026-05-20
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameHikma Pharmaceuticals USA Inc. | West-Ward Columbus Inc.2026-05-20
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameAlembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited2026-05-18
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameElite Laboratories, Inc.2026-05-15
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameSun Pharmaceutical Industries, Inc. | Orion Corporation, Orion Pharma | Orion Corporation ORION PHARMA2026-05-14
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameZydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited2026-05-09
These highlights do not include all the information needed to use TREXALL ® safely and effectively. See full prescribing information for TREXALL. TREXALL ® (methotrexate tablets), for oral use Initial U.S. Approval: 1953Product nameTeva Women's Health LLC2026-05-08
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameAurobindo Pharma Limited | EUGIA Pharma Specialities Limited2026-05-07
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameMylan Pharmaceuticals Inc.2026-05-07
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameMylan Pharmaceuticals Inc.2026-05-07
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameTeva Pharmaceuticals USA, Inc.2026-05-07
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameNuCare Pharmaceuticals, Inc.2026-04-30
These highlights do not include all the information needed to use METHOTREXATE INJECTION safely and effectively. See full prescribing information for METHOTREXATE INJECTION. METHOTREXATE injection, for intravenous, intramuscular, subcutaneous, or intrathecal use Initial U.S. Approval: 1953Product nameAlembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited2026-04-16
These highlights do not include all the information needed to use METHOTREXATE INJECTION safely and effectively. See full prescribing information for METHOTREXATE INJECTION. METHOTREXATE injection, for intravenous, intramuscular, subcutaneous, or intrathecal use Initial U.S. Approval: 1953Product nameAlembic Pharmaceuticals Limited2026-04-16
METHOTREXATE TABLETS. These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameGolden State Medical Supply, Inc.2026-04-15
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameSun Pharmaceutical Industries, Inc. | Orion Corporation, Orion Pharma | Orion Corporation ORION PHARMA2026-03-25
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameHikma Pharmaceuticals USA Inc. | West-Ward Columbus Inc.2026-03-17
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameElite Laboratories, Inc.2026-03-09
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameAurobindo Pharma Limited | EUGIA Pharma Specialities Limited2026-03-02
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameMylan Pharmaceuticals Inc.2026-02-15
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameA-S Medication Solutions2026-02-04
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameSafecor Health LLC2026-01-30
Methotrexate Tablets, USP Rx Only These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. Initial U.S. Approval: 1953Product nameAvPAK2026-01-29
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameSafecor Health LLC2026-01-21
Methotrexate Tablets, USP Rx Only These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. Initial U.S. Approval: 1953Product nameAvKARE2026-01-14
Methotrexate Tablets These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameChartwell RX, LLC2025-12-17
These highlights do not include all the information needed to use XATMEP ® safely and effectively. See full prescribing information for XATMEP. XATMEP (methotrexate) oral solution Initial U.S. Approval: 1953Product nameAzurity Pharmaceuticals, Inc.2025-12-16
These highlights do not include all the information needed to use JYLAMVO ® safely and effectively. See full prescribing information for JYLAMVO ® . JYLAMVO ® (methotrexate) oral solution Initial U.S. Approval: 1953Product nameSHORLA ONCOLOGY INC. | SHORLA PHARMA LTD. | SGS United Kingdom Limited2025-12-15
These highlights do not include all the information needed to use RASUVO ® safely and effectively. See full prescribing information for RASUVO. RASUVO (methotrexate) injection, for subcutaneous use Initial U.S. Approval: 1953Product nameMedexus Pharma Inc.2025-12-15
These highlights do not include all the information needed to use OTREXUP™ safely and effectively. See full prescribing information for OTREXUP . OTREXUP (methotrexate) injection, for subcutaneous use Initial U.S. Approval: 1953Product nameAssertio Specialty Pharmaceuticals, LLC | Pharmascience Inc. | Sharp Packaging Services, LLC | NeoPharm Labs Inc | PPD Development, L.P.2025-12-05
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameHikma Pharmaceuticals USA Inc. | West-Ward Columbus Inc.2025-12-03
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameAccord Healthcare Inc. | Intas Pharmaceuticals Limited2025-10-29
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameTeva Pharmaceuticals USA, Inc.2025-09-22
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameMajor Pharmaceuticals2025-09-15
These highlights do not include all the information needed to use METHOTREXATE INJECTION safely and effectively. See full prescribing information for METHOTREXATE INJECTION. METHOTREXATE injection, for intravenous, intramuscular, subcutaneous, or intrathecal use Initial U.S. Approval: 1953Product nameHospira, Inc. | Hospira Australia Pty Ltd2025-08-22
These highlights do not include all the information needed to use METHOTREXATE FOR INJECTION safely and effectively. See full prescribing information for METHOTREXATE FOR INJECTION . METHOTREXATE for Injection, for intravenous, intramuscular, subcutaneous, or intrathecal use Initial U.S. Approval: 1953Product nameFresenius Kabi USA, LLC2025-08-19
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameMylan Institutional Inc.2025-07-22
METHOTREXATE-methotrexate for injection, powder, lyophilized, for solution Hikma Pharmaceuticals USA Inc. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use METHOTREXATE FOR INJECTION safely and effectively. See full prescribing information for METHOTREXATE FOR INJECTION. METHOTREXATE for injection, for intravenous, intramuscular, subcutaneous, or intrathecal use Initial U.S. Approval: 1953Product nameHikma Pharmaceuticals USA Inc.2025-07-17
These highlights do not include all the information needed to use METHOTREXATE INJECTION safely and effectively. See full prescribing information for METHOTREXATE INJECTION. METHOTREXATE injection, for intravenous, intramuscular, subcutaneous, or intrathecal use Initial U.S. Approval: 1953Product nameTeva Parenteral Medicines, Inc.2025-07-15
These highlights do not include all the information needed to use METHOTREXATE INJECTION safely and effectively. See full prescribing information for METHOTREXATE INJECTION. METHOTREXATE injection, for intravenous, intramuscular, subcutaneous, or intrathecal use Initial U.S. Approval: 1953Product nameEugia US LLC | Mylan Laboratories Limited | EUGIA Pharma Specialities Limited2025-07-10
These highlights do not include all the information needed to use METHOTREXATE INJECTION safely and effectively. See full prescribing information for METHOTREXATE INJECTION. METHOTREXATE injection, for intravenous, intramuscular, subcutaneous, or intrathecal use Initial U.S. Approval: 1953Product nameHospira, Inc. | Hospira Australia Pty Ltd2025-06-30
These highlights do not include all the information needed to use METHOTREXATE INJECTION safely and effectively. See full prescribing information for METHOTREXATE INJECTION. METHOTREXATE injection, for intravenous, intramuscular, subcutaneous, or intrathecal use Initial U.S. Approval: 1953Product nameHospira, Inc. | Hospira Australia Pty Ltd2025-06-10
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameCoupler LLC2025-02-27
These highlights do not include all the information needed to use OTREXUP™ safely and effectively. See full prescribing information for OTREXUP . OTREXUP (methotrexate) injection, for subcutaneous use Initial U.S. Approval: 1953Product nameAntares Pharma, Inc. | Pharmascience Inc. | Sharp Packaging Services, LLC | NeoPharm Labs Inc | PPD Development, L.P.2025-01-31
These highlights do not include all the information needed to use METHOTREXATE INJECTION safely and effectively. See full prescribing information for METHOTREXATE INJECTION. METHOTREXATE injection, for intravenous, intramuscular, subcutaneous, or intrathecal use Initial U.S. Approval: 1953Product nameAccord Healthcare, Inc. | Intas Pharmaceuticals Limited2025-01-14
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameNuCare Pharmaceuticals, Inc.2025-01-14
Methotrexate tablet, USPProduct nameZydus Lifesciences Limited | Zydus Pharmaceuticals USA Inc.2024-12-05
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameBryant Ranch Prepack2024-10-01
METHOTREXATE INJECTION, USP METHOTREXATE FOR INJECTION, USPProduct nameHikma Pharmaceuticals USA Inc.2024-09-05
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameProficient Rx LP2024-08-01
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameAlembic Pharmaceuticals Limited2024-06-07
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameAlembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited2024-06-04
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameBryant Ranch Prepack2024-05-17
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameBryant Ranch Prepack2023-12-07
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameAccord Healthcare Inc. | Intas Pharmaceuticals Limited2023-12-02
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameTeva Pharmaceuticals USA, Inc.2023-08-21
These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets, for oral use Initial U.S. Approval: 1953Product nameBryant Ranch Prepack2023-08-15
These highlights do not include all the information needed to use METHOTREXATE INJECTION safely and effectively. See full prescribing information for METHOTREXATE INJECTION. METHOTREXATE injection, for intravenous, intramuscular, subcutaneous, or intrathecal use Initial U.S. Approval: 1953Product nameHikma Pharmaceuticals USA Inc.2023-04-17
These highlights do not include all the information needed to use TREXALL ® safely and effectively. See full prescribing information for TREXALL. TREXALL ® (methotrexate tablets), for oral use Initial U.S. Approval: 1953Product nameTeva Women's Health, Inc.2021-04-30
Methotrexate Injection, USPProduct nameFresenius Kabi USA, LLC2021-03-24
Methotrexate Tablets USPProduct nameA-S Medication Solutions2018-08-23