FDA.reportPublic FDA data

NDC 50268-554-11 - 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
50268-554
Requested NDC
50268-554-11
Package NDCs from labels
50268-554-11, 50268-554-15
Manufacturer
AvPAK
Effective date
2026-01-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Methotrexate - AvPAKAvPAK2026-01-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-554-11Methotrexate1 in 1 BLISTER PACKTABLET11
50268-554-15Methotrexate50 in 1 BOXTABLET501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-554-11EA - Each50268-5540668ad87-9e70-4d65-99f0-c1b350413a6012026-03-17
50268-554-15EA - Each50268-5544e603a55-a2d1-40a9-9ae9-9b8e4708888812026-03-17

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 · 42 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethotrexateMETHOTREXATEAccord Healthcare, Inc.dd035a9f-cd40-4314-b9d8-2294b8a924e22026-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: YL5FZ2Y5U1
MethotrexateMETHOTREXATEA-S Medication Solutions22e10810-16fb-4c84-bccf-972405b77ef82026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
MethotrexateMETHOTREXATEAvKARE757d6cef-6696-7a1c-8074-01258aaa8bdd2026-07-23Boxed warning, Adverse reactionsExact identifier
rxcui: 105585
MethotrexateMETHOTREXATEBryant Ranch Prepackb6e61c50-024a-494f-b04c-100fb371a8372026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
JYLAMVOMETHOTREXATESHORLA ONCOLOGY INC.96e931f5-51ae-4bdf-a441-bb0dd26d4c0e2026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: YL5FZ2Y5U1
MethotrexateMETHOTREXATEBryant Ranch Prepack0b54b5c4-2466-4f85-b9a0-ad93ec4a06a12026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
MethotrexateMETHOTREXATETeva Pharmaceuticals USA, Inc.9b34b1d8-d125-41a2-9f6f-3fab67b573bd2026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
MethotrexateMETHOTREXATEMajor Pharmaceuticals2a6afc4c-819d-4ba9-8040-4504519c116a2026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207812
rxcui: 105585
unii: YL5FZ2Y5U1
XatmepMETHOTREXATEAzurity Pharmaceuticals, Inc.aec9984e-34c5-481b-b6bf-9bb5caf1daf82026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: YL5FZ2Y5U1
MethotrexateMETHOTREXATEAccord Healthcare Inc.874c7f43-a3be-4236-89cc-24c44e3c58132026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
METHOTREXATEMETHOTREXATEBryant Ranch Prepack4a04756f-e1c9-4d1e-b309-7be31c9176d62026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
Methotrexate SodiumMETHOTREXATE SODIUMElite Laboratories, Inc.89c05ea3-3be1-46dd-b112-29c436fd72892026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
MethotrexateMETHOTREXATE SODIUMSun Pharmaceutical Industries, Inc.8f1260de-b60c-4f0e-8af6-0e957b0a281b2026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
Methotrexate SodiumMETHOTREXATE SODIUMHikma Pharmaceuticals USA Inc.d71b1856-99d8-4a9e-9189-f87b6675f80a2026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
MethotrexateMETHOTREXATEBryant Ranch Prepack4741a44f-0d0b-4380-84f6-231a8d1560fb2026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
METHOTREXATEMETHOTREXATEAlembic Pharmaceuticals Inc.04a95db9-a124-4b97-bd71-1c37a6b3b0c82026-05-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
MethotrexateMETHOTREXATEZydus Pharmaceuticals USA Inc.948e0bab-6524-4b87-9853-1799d44155582026-05-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207812
ndc (product): 68382-775
rxcui: 105585
spl id: 5d9b7269-19d4-4d2c-b252-f3ff759dffa5
spl set id: 948e0bab-6524-4b87-9853-1799d4415558
unii: YL5FZ2Y5U1
MethotrexateMETHOTREXATEMylan Pharmaceuticals Inc.70c09984-2b36-424f-8b27-3fd0cd4e833d2026-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
MethotrexateMETHOTREXATEAurobindo Pharma Limited09931d44-a3f8-49dc-a3f2-b527ee4214bf2026-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
MethotrexateMETHOTREXATENuCare Pharmaceuticals, Inc.50b2cfc7-dfe4-4406-e063-6294a90a25272026-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585

Reported adverse events (FAERS/openFDA)#

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