FDA.reportPublic FDA data

NDC 75840-111-01 - METHOTREXATE SODIUM

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
75840-111
Requested NDC
75840-111-01
Package NDCs from labels
75840-111-01, 75840-111-00
Manufacturer
GenPak Solutions LLC
Effective date
2012-07-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
METHOTREXATE SODIUM - GenPak Solutions LLCGenPak Solutions LLC2012-07-09HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75840-111-002020-01-31C16284748780-19d75b9d0-2bff-f424-e053-dadaa90a57ceb78cd35a-31ae-4404-9b15-eaffaaba42a0

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHOTREXATE SODIUMACTIVE INGREDIENT3IG1E710ZNMETHOTREXATE SODIUM TABLET [GENPAK SOLUTIONS LLC]1
METHOTREXATEACTIVE MOIETYYL5FZ2Y5U1METHOTREXATE SODIUM TABLET [GENPAK SOLUTIONS LLC]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GMETHOTREXATE SODIUM TABLET [GENPAK SOLUTIONS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHOTREXATE SODIUM TABLET [GENPAK SOLUTIONS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETHOTREXATE SODIUM TABLET [GENPAK SOLUTIONS LLC]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.

Matched openFDA labels page 2 of 3 · 59 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethotrexateMETHOTREXATEGolden State Medical Supply, Inc.6f14ced9-c16b-905a-e053-2a91aa0a031e2026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3IG1E710ZN
MethotrexateMETHOTREXATESafecor Health LLCf177e6fa-c482-432d-8208-937468ab3f102026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3IG1E710ZN
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
B03 Sinus ReliefALLIUM CEPA, CALCAREA IODATA, CALCAREA SULPHURICA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, EUPHORBIUM OFFICINARUM, HEPAR SULPHURIS CALCAREUM, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, KALI MURIATICUM, KALI SULPHURICUM, LAC DEFLORATUM, LUFFA OPERCULATA, MERCURIUS SULPHURATUS RUBER, PHOSPHORUS, PULSATILLA VULGARIS, SACCHARUM LACTIS, THUJA OCCIDENTALISApex Energetics Inc.bad83f77-e9ae-7118-e053-2a95a90aa7372025-12-31WarningsExact identifier
unii: J2B2A4N98G
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
MethotrexateMETHOTREXATEChartwell RX, LLC2609da8f-80dc-448e-8eba-35d11488ce7f2025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3IG1E710ZN
RasuvoMETHOTREXATEMedexus Pharma Inc.d0075461-0e7e-4967-9c9b-d6440e912c0e2025-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3IG1E710ZN
Sugar CravingsCINNAMIC ACID, PHLORIDZINUM, ARGENTUM NITRICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, BEET SUGAR, DEXTROSE, D-RIBOSE, FRUCTOSE, LYCOPODIUM CLAVATUM, MAPLE SUGAR, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, MALVIN, ADRENOCORTICOTROPHIN, DYSENTERY BACILLUS, MORGAN GAERTNERDr. Donna Restivo DC401873ba-ae1b-4506-a2e8-c6c0e5ff27f52025-10-21WarningsExact identifier
unii: J2B2A4N98G
MethotrexateMETHOTREXATEHospira, Inc.0e30eaef-5a09-4104-8a11-c32933eadeab2025-08-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3IG1E710ZN
MethotrexateMETHOTREXATE SODIUMFresenius Kabi USA, LLCec476b11-0b3c-4139-b1eb-a3daa76bc2712025-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3IG1E710ZN
Dairy-Grain-NightshadeIRIS VERS., SOLIDAGO, ANTIMON. CRUD., ARG. NIT., ARSENICUM ALB., AVENA, BAPTISIA, BELLADONNA, BRYONIA, CAPSICUM, CARDUUS BEN., CINCHONA, DULCAMARA, FAGOPYRUM, GELSEMIUM, HYOSCYAMUS, IPECAC., LAC VAC., LACHESIS, LYCOPODIUM, NAT. MUR., PHOS., PODOPH. PELT., PULSATILLA, RHUS TOX., SAC. LAC., SECALE, SEPIA, STRAMONIUM, TABACUM, TRITICUM, USTILAGO MAIDIS, VERBASCUM, LYCOPERSICUM, SOLANUM NIG., SOLANUM TUB., STIGMATA, TORULA CEREVISIAE.Newton Laboratories, Inc.99fcbd61-ecc8-cf9d-e053-2995a90aebeb2025-07-25WarningsExact identifier
unii: J2B2A4N98G
MethotrexateMETHOTREXATEMylan Institutional Inc.8df0780e-0fbd-4ab8-80b0-7a5eaa08ec0a2025-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3IG1E710ZN
MethotrexateMETHOTREXATETeva Parenteral Medicines, Inc.346ec9ce-dc98-4a55-b55e-d3af11f2d7032025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3IG1E710ZN
METHOTREXATEMETHOTREXATEEugia US LLC63bb6fbf-dd59-4edc-af8f-d0c397ca12622025-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3IG1E710ZN
MethotrexateMETHOTREXATEHospira, Inc.bd287e89-32f9-4396-95fa-4b562869f4762025-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3IG1E710ZN
MethotrexateMETHOTREXATEHospira, Inc.0d63ba29-b692-41b4-87e8-351265c8273f2025-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3IG1E710ZN
MethotrexateMETHOTREXATECoupler LLC2f20d43e-a4b3-a839-e063-6394a90ace382025-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3IG1E710ZN
Dairy-Grain-NightshadesIRIS VERS., SOLIDAGO, ANTIMON. CRUD., ARG. NIT., ARSENICUM ALB., AVENA, BAPTISIA, BELLADONNA, BRYONIA, CAPSICUM, CARDUUS BEN., CINCHONA, DULCAMARA, FAGOPYRUM, GELSEMIUM, HYOSCYAMUS, IPECAC., LAC VAC., LACHESIS, LYCOPODIUM, NAT. MUR., PHOS., PODOPH. PELT., PULSATILLA, RHUS TOX., SAC. LAC., SECALE, SEPIA, STRAMONIUM, TABACUM, TRITICUM, USTILAGO MAIDIS, VERBASCUM, LYCOPERSICUM, SOLANUM NIG., SOLANUM TUB., STIGMATA, TORULA CEREVISIAE.Newton Laboratories, Inc.9ba83c60-35be-181a-e053-2a95a90a98952025-02-06WarningsExact identifier
unii: J2B2A4N98G
MethotrexateMETHOTREXATENuCare Pharmaceuticals, Inc.2b61822e-b488-5eaf-e063-6394a90a2dcd2025-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3IG1E710ZN
MethotrexateMETHOTREXATEBryant Ranch Prepacke6611304-4622-4b2e-9b94-57fbad023ae22024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3IG1E710ZN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.