FDA.reportPublic FDA data

NDC 72162-2647-02 - 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
72162-2647
Requested NDC
72162-2647-02
Package NDCs from labels
72162-2647-1, 72162-2647-2, 72162-2647-02
Manufacturer
Bryant Ranch Prepack
Effective date
2026-05-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
METHOTREXATE - Bryant Ranch PrepackBryant Ranch Prepack2026-05-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2647-1METHOTREXATE100 in 1 BOTTLETABLET100101
72162-2647-2METHOTREXATE36 in 1 BOTTLETABLET36101

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 · 46 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
rxcui: 105585
unii: 3IG1E710ZN
MethotrexateMETHOTREXATEAvKARE757d6cef-6696-7a1c-8074-01258aaa8bdd2026-07-23Boxed warning, Adverse reactionsExact identifier
rxcui: 105585
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
rxcui: 105585
unii: 3IG1E710ZN
MethotrexateMETHOTREXATEBryant Ranch Prepack0b54b5c4-2466-4f85-b9a0-ad93ec4a06a12026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
unii: 3IG1E710ZN
MethotrexateMETHOTREXATETeva Pharmaceuticals USA, Inc.9b34b1d8-d125-41a2-9f6f-3fab67b573bd2026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
unii: 3IG1E710ZN
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
application number: ANDA217552
ndc (package): 72162-2647-1
ndc (package): 72162-2647-2
ndc (product): 72162-2647
ndc11 (package): 72162264702
rxcui: 105585
spl id: e435ace3-53d5-48a9-b0f8-4e11b06a8800
spl set id: 4a04756f-e1c9-4d1e-b309-7be31c9176d6
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
METHOTREXATEMETHOTREXATEAlembic Pharmaceuticals Inc.04a95db9-a124-4b97-bd71-1c37a6b3b0c82026-05-18Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA217552
ndc (product): 62332-730
rxcui: 105585
spl id: 9dd138d6-6889-400e-a994-9931af68244a
spl set id: 04a95db9-a124-4b97-bd71-1c37a6b3b0c8
unii: 3IG1E710ZN
MethotrexateMETHOTREXATEZydus Pharmaceuticals USA Inc.948e0bab-6524-4b87-9853-1799d44155582026-05-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
MethotrexateMETHOTREXATEMylan Pharmaceuticals Inc.70c09984-2b36-424f-8b27-3fd0cd4e833d2026-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
unii: 3IG1E710ZN
MethotrexateMETHOTREXATEAurobindo Pharma Limited09931d44-a3f8-49dc-a3f2-b527ee4214bf2026-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
unii: 3IG1E710ZN
MethotrexateMETHOTREXATENuCare Pharmaceuticals, Inc.50b2cfc7-dfe4-4406-e063-6294a90a25272026-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
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

Reported adverse events (FAERS/openFDA)#

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