FDA.reportPublic FDA data

NDC 48433-065-01 - Methotrexate

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
48433-065
Requested NDC
48433-065-01
Package NDCs from labels
48433-065-01, 48433-065-05
Manufacturer
Safecor Health LLC
Effective date
2026-01-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Methotrexate - Safecor Health LLCSafecor Health LLC2026-01-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48433-065-01Methotrexate1 in 1 BLISTER PACKTABLET12
48433-065-05Methotrexate20 in 1 CARTONTABLET202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
48433-065-05EA - Each48433-0659323610b-703d-4b26-aa83-8eaef092205012026-05-22

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 4 of 33 · 649 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethotrexateMETHOTREXATETeva Pharmaceuticals USA, Inc.9b34b1d8-d125-41a2-9f6f-3fab67b573bd2026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
unii: 3IG1E710ZN
BM Silicea Icing SugarSILICEA ICING SUGARTotal Operations Management LLC DBA:Bestmade Natural Products Micro535ba100-627f-36b4-e063-6394a90a33732026-06-03WarningsExact identifier
unii: ETJ7Z6XBU4
BM Tooth RemineralizationCALC PHOS, CALC FLUOR, SILICEABM Private Limited5331dc40-2ac8-5fce-e063-6394a90a58752026-06-01WarningsExact identifier
unii: ETJ7Z6XBU4
MethotrexateMETHOTREXATEMajor Pharmaceuticals2a6afc4c-819d-4ba9-8040-4504519c116a2026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
MethotrexateMETHOTREXATEAccord Healthcare Inc.874c7f43-a3be-4236-89cc-24c44e3c58132026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
unii: 3IG1E710ZN
METHOTREXATEMETHOTREXATEBryant Ranch Prepack4a04756f-e1c9-4d1e-b309-7be31c9176d62026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
unii: 3IG1E710ZN
Methotrexate SodiumMETHOTREXATE SODIUMElite Laboratories, Inc.89c05ea3-3be1-46dd-b112-29c436fd72892026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
unii: 3IG1E710ZN
MethotrexateMETHOTREXATE SODIUMSun Pharmaceutical Industries, Inc.8f1260de-b60c-4f0e-8af6-0e957b0a281b2026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
unii: 3IG1E710ZN
Methotrexate SodiumMETHOTREXATE SODIUMHikma Pharmaceuticals USA Inc.d71b1856-99d8-4a9e-9189-f87b6675f80a2026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
unii: 3IG1E710ZN
MethotrexateMETHOTREXATEBryant Ranch Prepack4741a44f-0d0b-4380-84f6-231a8d1560fb2026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
unii: 3IG1E710ZN
DentaforceANTIMONIUM CRUDUM, BELLADONNA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, MERCURIUS SOLUBILIS, PLUMBUM METALLICUM, SEPIA, SILICEA, HYDROFLUORICUM ACIDUMBioActive Nutritional, Inc.82321547-e04a-42ff-aa39-6a192638e5a22026-05-18WarningsExact identifier
unii: ETJ7Z6XBU4
METHOTREXATEMETHOTREXATEAlembic Pharmaceuticals Inc.04a95db9-a124-4b97-bd71-1c37a6b3b0c82026-05-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
unii: 3IG1E710ZN
C07 STRONG LIGAMENTS AND JOINTSARNICA MONTANA, ASCORBICUM ACIDUM, BOS TAURUS LYMPH VESSEL, INTERVERTEBRAL FIBROCARTILAGE, BOS TAURUS MESENCHYME, CALCAREA PHOSPHORICA, CARTILAGO SUIS, FORMICUM ACIDUM, LAPIS ALBUS, PINUS MONTANA LEAFY TWIG, RHAMNUS CALIFORNICA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SUS SCROFA JOINT ENVELOPE, SUS SCROFA LIGAMENT, SUS SCROFA MENISCUS, SUS SCROFA PARATHYROID GLAND, SUS SCROFA VEIN, SYMPHYTUM OFFICINALEApex Energetics Inc.bccf8c83-a6cd-e58c-e053-2a95a90a43d72026-05-13WarningsExact identifier
unii: ETJ7Z6XBU4
MethotrexateMETHOTREXATEZydus Pharmaceuticals USA Inc.948e0bab-6524-4b87-9853-1799d44155582026-05-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
Acne ReliefBELLADONNA, SILICEA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, KALI BROMATUM, LEDUM PALUSTRE, NATRUM MURIATICUM, SELENIUM, SULPHURNaturalCare487b1373-b78c-4510-964a-6ab0fe781ff42026-05-08WarningsExact identifier
unii: ETJ7Z6XBU4
MethotrexateMETHOTREXATEMylan Pharmaceuticals Inc.70c09984-2b36-424f-8b27-3fd0cd4e833d2026-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA081235
ndc (product): 0378-0014
rxcui: 105585
spl id: 01ad6cb9-5879-4c06-801b-0de84eebaae7
spl set id: 70c09984-2b36-424f-8b27-3fd0cd4e833d
unii: 3IG1E710ZN
MethotrexateMETHOTREXATEAurobindo Pharma Limited09931d44-a3f8-49dc-a3f2-b527ee4214bf2026-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
unii: 3IG1E710ZN
DentastatALLIUM SATIVUM, BERBERIS VULGARIS, FUCUS VESICULOSUS, PHYTOLACCA DECANDRA, ARGENTUM METALLICUM, AURUM METALLICUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, IODIUM, MERCURIUS SOLUBILIS, NICCOLUM METALLICUM, SILICEA, ZINCUM METALLICUM, PLATINUM METALLICUMEnergique, Inc.12786efd-df42-4321-bfdf-88f542d387bb2026-05-06WarningsExact identifier
unii: ETJ7Z6XBU4
Age Defiance Pro7-OXO-DEHYDROEPIANDROSTERONE-3B-ACETATE, CALCAREA CARBONICA, CONIUM MACULATUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HYDROFLUORICUM ACIDUM, HYPOPHYSIS SUIS, LYCOPODIUM CLAVATUM, SELENIUM METALLICUM, SEPIA, SILICEA, HUMAN GROWTH HORMONEEnergique, Inc.d528bdbe-fb75-4b13-9cbc-efa2177d74d82026-05-06WarningsExact identifier
unii: ETJ7Z6XBU4
Pollen HayfeverADRENALINUM, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM IODATUM, MUGWORT POLLEN (ARTEMISIA VULGARIS), BELLIS PERENNIS, BRASSICA SPP, CHENOPODIUM ALBUM, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, ALFALFA POLLEN (MEDICAGO SATIVA), PHLEUM PRATENSE, YELLOW DOCK POLLEN (RUMEX CRISPUS), SABADILLA, SILICEA, GOLDENROD POLLEN (SOLIDAGO CANADENSIS), DANDELION POLLEN (TARAXACUM OFFICINALE), RED CLOVER POLLEN (TRIFOLIUM PRATENSE), XANTHIUM STRUMARIUMNaturalCare00665933-176e-4f16-b6ee-b55217b8abb32026-05-05WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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