Home NDC 71335-2221 Methotrexate
Product NDC 71335-2221
11-digit product format 713352221
Labeler code 71335
Product ID 71335-2221_5488dfc1-8f40-4f52-ab27-f08e77b8c5c8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methotrexate
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA210454
Marketing category ANDA
Marketing start 2020-01-30
Substance METHOTREXATE SODIUM
Active strength 2.5 mg/1
Pharmacologic classes Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210454-001 METHOTREXATE SODIUM METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210454-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A210454-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210454-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210454-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210454-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210454-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210454-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210454-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210454-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210454-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210454-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210454-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210454-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210454-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210454-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210454-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210454-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210454-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210454-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-30 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A210454-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210454-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210454-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210454-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210454-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210454-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-30 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210454-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210454-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210454-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210454-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210454-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210454-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210454-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210454-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210454-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210454-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210454-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210454-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210454-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-30 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210454-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-30 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Methotrexate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHOTREXATE SODIUM 2.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3IG1E710ZN Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 105585 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-2221 METHOTREXATE TABLET [BRYANT RANCH PREPACK] 100 Current NDC, 8 package rows 20230824_b6e61c50-024a-494f-b04c-100fb371a837.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 1 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Methotrexate METHOTREXATE Bryant Ranch Prepack b6e61c50-024a-494f-b04c-100fb371a837 2026-06-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210454 application number: ANDA210454 ndc (product): 71335-2221 Methotrexate METHOTREXATE Aurobindo Pharma Limited 09931d44-a3f8-49dc-a3f2-b527ee4214bf 2026-05-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210454 application number: ANDA210454 Methotrexate METHOTREXATE Chartwell RX, LLC 2609da8f-80dc-448e-8eba-35d11488ce7f 2025-12-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210454 application number: ANDA210454 Methotrexate METHOTREXATE NuCare Pharmaceuticals, Inc. 2b61822e-b488-5eaf-e063-6394a90a2dcd 2025-01-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210454 application number: ANDA210454
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71335-2221-1 71335222101 30 TABLET in 1 BOTTLE (71335-2221-1) 30 tablet 2023-08-15 No No Current 71335-2221-2 71335222102 12 TABLET in 1 BOTTLE (71335-2221-2) 12 tablet 2023-08-15 No No Current 71335-2221-3 71335222103 20 TABLET in 1 BOTTLE (71335-2221-3) 20 tablet 2023-08-15 No No Current 71335-2221-4 71335222104 100 TABLET in 1 BOTTLE (71335-2221-4) 100 tablet 2023-08-15 No No Current 71335-2221-5 71335222105 36 TABLET in 1 BOTTLE (71335-2221-5) 36 tablet 2023-08-15 No No Current 71335-2221-6 71335222106 24 TABLET in 1 BOTTLE (71335-2221-6) 24 tablet 2023-08-15 No No Current 71335-2221-7 71335222107 90 TABLET in 1 BOTTLE (71335-2221-7) 90 tablet 2023-08-15 No No Current 71335-2221-8 71335222108 4 TABLET in 1 BOTTLE (71335-2221-8) 4 tablet 2023-08-15 No No Current