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 1 of 3 · 59 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethotrexateMETHOTREXATEA-S Medication Solutions22e10810-16fb-4c84-bccf-972405b77ef82026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3IG1E710ZN
MethotrexateMETHOTREXATEAvKARE757d6cef-6696-7a1c-8074-01258aaa8bdd2026-07-23Boxed warning, Adverse reactionsExact identifier
unii: 3IG1E710ZN
TrexallMETHOTREXATETeva Women's Health LLCe942f8db-510f-44d6-acb5-b822196f5e8c2026-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3IG1E710ZN
MethotrexateMETHOTREXATEBryant Ranch Prepackb6e61c50-024a-494f-b04c-100fb371a8372026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3IG1E710ZN
MethotrexateMETHOTREXATEBryant Ranch Prepack0b54b5c4-2466-4f85-b9a0-ad93ec4a06a12026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3IG1E710ZN
MethotrexateMETHOTREXATETeva Pharmaceuticals USA, Inc.9b34b1d8-d125-41a2-9f6f-3fab67b573bd2026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3IG1E710ZN
MethotrexateMETHOTREXATEAccord Healthcare Inc.874c7f43-a3be-4236-89cc-24c44e3c58132026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3IG1E710ZN
METHOTREXATEMETHOTREXATEBryant Ranch Prepack4a04756f-e1c9-4d1e-b309-7be31c9176d62026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3IG1E710ZN
Methotrexate SodiumMETHOTREXATE SODIUMElite Laboratories, Inc.89c05ea3-3be1-46dd-b112-29c436fd72892026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3IG1E710ZN
MethotrexateMETHOTREXATE SODIUMSun Pharmaceutical Industries, Inc.8f1260de-b60c-4f0e-8af6-0e957b0a281b2026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3IG1E710ZN
Methotrexate SodiumMETHOTREXATE SODIUMHikma Pharmaceuticals USA Inc.d71b1856-99d8-4a9e-9189-f87b6675f80a2026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3IG1E710ZN
MethotrexateMETHOTREXATEBryant Ranch Prepack4741a44f-0d0b-4380-84f6-231a8d1560fb2026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3IG1E710ZN
METHOTREXATEMETHOTREXATEAlembic Pharmaceuticals Inc.04a95db9-a124-4b97-bd71-1c37a6b3b0c82026-05-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3IG1E710ZN
MethotrexateMETHOTREXATEMylan Pharmaceuticals Inc.70c09984-2b36-424f-8b27-3fd0cd4e833d2026-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3IG1E710ZN
MethotrexateMETHOTREXATEAurobindo Pharma Limited09931d44-a3f8-49dc-a3f2-b527ee4214bf2026-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3IG1E710ZN
MethotrexateMETHOTREXATENuCare Pharmaceuticals, Inc.50b2cfc7-dfe4-4406-e063-6294a90a25272026-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3IG1E710ZN
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
METHOTREXATEMETHOTREXATEAlembic Pharmaceuticals Inc.a63364d5-4dfa-49d7-8a5e-c8959ae1d37a2026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3IG1E710ZN
METHOTREXATEMETHOTREXATEAlembic Pharmaceuticals Limitede98b2abd-8068-482e-9ce3-1ab262f0838e2026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3IG1E710ZN

Reported adverse events (FAERS/openFDA)#

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