NDC 70771-1058-01 - 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
70771-1058
Requested NDC
70771-1058-01
Package NDCs from labels
70771-1058-3, 70771-1058-9, 70771-1058-1, 70771-1058-5, 70771-1058-0, 70771-1058-2, 70771-1058-7, 70771-1058-01
Manufacturer
Zydus Lifesciences Limited | Zydus Pharmaceuticals USA Inc.
Effective date
2024-12-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Methotrexate tablet, USPZydus Lifesciences Limited | Zydus Pharmaceuticals USA Inc.2024-12-05HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1058-0Methotrexate1000 in 1 BOTTLETABLET10008
70771-1058-1Methotrexate100 in 1 BOTTLETABLET1008
70771-1058-2Methotrexate1 in 1 BLISTER PACKTABLET18
70771-1058-3Methotrexate36 in 1 BOTTLETABLET368
70771-1058-5Methotrexate500 in 1 BOTTLETABLET5008
70771-1058-7Methotrexate100 in 1 CARTONTABLET1008
70771-1058-9Methotrexate90 in 1 BOTTLETABLET908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1058METHOTREXATE TABLET [ZYDUS LIFESCIENCES LIMITED]8Current NDC, Legacy NDC, 7 package rows20241207_59ea7b32-2b6d-4197-92c3-015936f04ebe.zip

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
rxcui: 105585
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.