FDA.reportPublic FDA data

NDC 16729-486-36 - 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
16729-486
Requested NDC
16729-486-36
Package NDCs from labels
16729-486-36, 16729-486-01
Manufacturer
Accord Healthcare Inc. | Intas Pharmaceuticals Limited
Effective date
2026-05-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Methotrexate - Accord Healthcare Inc. | Intas Pharmaceuticals LimitedAccord Healthcare Inc. | Intas Pharmaceuticals Limited2026-05-27HUMAN PRESCRIPTION DRUG LABEL
Methotrexate - Bryant Ranch PrepackBryant Ranch Prepack2026-05-20HUMAN PRESCRIPTION DRUG LABEL
Methotrexate - NuCare Pharmaceuticals, Inc.NuCare Pharmaceuticals, Inc.2026-04-30HUMAN PRESCRIPTION DRUG LABEL
Methotrexate - Coupler LLCCoupler LLC2025-02-27HUMAN PRESCRIPTION DRUG LABEL
Methotrexate - Proficient Rx LPProficient Rx LP2024-08-01HUMAN PRESCRIPTION DRUG LABEL
Methotrexate - REMEDYREPACK INC.REMEDYREPACK INC.2024-03-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-486-01Methotrexate100 in 1 BOTTLETABLET1008
16729-486-36Methotrexate36 in 1 BOTTLETABLET368

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-486METHOTREXATE TABLET [ACCORD HEALTHCARE INC.]6Current NDC, Legacy NDC, 2 package rows20231203_874c7f43-a3be-4236-89cc-24c44e3c5813.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 · 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
application number: ANDA213343
ndc (package): 16729-486-36
ndc (package): 16729-486-01
ndc (product): 16729-486
ndc11 (package): 16729048636
rxcui: 105585
spl id: 52d366f6-f339-ff1a-e063-6294a90a1577
spl set id: 874c7f43-a3be-4236-89cc-24c44e3c5813
unii: 3IG1E710ZN
METHOTREXATEMETHOTREXATEBryant Ranch Prepack4a04756f-e1c9-4d1e-b309-7be31c9176d62026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
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
application number: ANDA213343
ndc (package): 71335-1772-6
ndc (package): 71335-1772-5
ndc (package): 71335-1772-2
ndc (package): 71335-1772-7
ndc (package): 71335-1772-4
ndc (package): 71335-1772-8
ndc (package): 71335-1772-1
ndc (package): 71335-1772-3
ndc (product): 71335-1772
rxcui: 105585
spl id: 17125571-6b01-40cb-ab78-7b9f4f8cc16c
spl set id: 4741a44f-0d0b-4380-84f6-231a8d1560fb
unii: 3IG1E710ZN
METHOTREXATEMETHOTREXATEAlembic Pharmaceuticals Inc.04a95db9-a124-4b97-bd71-1c37a6b3b0c82026-05-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 105585
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
application number: ANDA213343
ndc (package): 68071-3991-9
ndc (product): 68071-3991
rxcui: 105585
spl id: 50b2d5ac-f9bb-4f80-e063-6294a90a933b
spl set id: 50b2cfc7-dfe4-4406-e063-6294a90a2527
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.