FDA.reportPublic FDA data

NDC 70771-1058-2 - 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
70771-1058-2
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
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 2 of 3 · 42 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
MethotrexateMETHOTREXATEGolden State Medical Supply, Inc.6f14ced9-c16b-905a-e053-2a91aa0a031e2026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
MethotrexateMETHOTREXATESafecor Health LLCf177e6fa-c482-432d-8208-937468ab3f102026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
MethotrexateMETHOTREXATEAvPAK4992fdaa-b880-ee25-e063-6394a90af03b2026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207812
rxcui: 105585
unii: YL5FZ2Y5U1
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
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
rxcui: 105585
MethotrexateMETHOTREXATEMylan Institutional Inc.8df0780e-0fbd-4ab8-80b0-7a5eaa08ec0a2025-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
MethotrexateMETHOTREXATEHikma Pharmaceuticals USA Inc.b080eb92-fc72-4ce6-a7ab-3f9ce24155262025-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: YL5FZ2Y5U1
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
MethotrexateMETHOTREXATECoupler LLC2f20d43e-a4b3-a839-e063-6394a90ace382025-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
OtrexupMETHOTREXATEAntares Pharma, Inc.9ab8ce16-f7de-41d4-a4c8-1c742621b6d52025-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: YL5FZ2Y5U1
MethotrexateMETHOTREXATENuCare Pharmaceuticals, Inc.2b61822e-b488-5eaf-e063-6394a90a2dcd2025-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
MethotrexateMETHOTREXATEZydus Lifesciences Limited59ea7b32-2b6d-4197-92c3-015936f04ebe2024-12-05Exact identifier
application number: ANDA207812
ndc (package): 70771-1058-9
ndc (package): 70771-1058-5
ndc (package): 70771-1058-1
ndc (package): 70771-1058-3
ndc (package): 70771-1058-7
ndc (package): 70771-1058-0
ndc (package): 70771-1058-2
ndc (product): 70771-1058
ndc11 (package): 70771105802
rxcui: 105585
spl id: ae399908-cfb6-44dc-83da-8981f5dabbb8
spl set id: 59ea7b32-2b6d-4197-92c3-015936f04ebe
unii: YL5FZ2Y5U1
MethotrexateMETHOTREXATEBryant Ranch Prepacke6611304-4622-4b2e-9b94-57fbad023ae22024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
MethotrexateMETHOTREXATEHikma Pharmaceuticals USA Inc.8593f7fc-eabe-44ae-bb05-b3d7d408e4f72024-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: YL5FZ2Y5U1
MethotrexateMETHOTREXATEProficient Rx LPa76808f0-38a7-4b54-a4fb-3584f9058ae52024-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
METHOTREXATEMETHOTREXATEAlembic Pharmaceuticals Limitedff55c573-dc84-4ff3-9d10-2b24c47dd6792024-06-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ

Reported adverse events (FAERS/openFDA)#

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