Home NDC 82804-136 Methotrexate
Product NDC 82804-136
11-digit product format 828040136
Labeler code 82804
Product ID 82804-136_a76808f0-38a7-4b54-a4fb-3584f9058ae5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methotrexate
Dosage form TABLET
Route ORAL
Labeler Proficient Rx LP
Application ANDA213343
Marketing category ANDA
Marketing start 2020-08-24
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 A213343-001 METHOTREXATE SODIUM METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213343-001 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 A213343-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213343-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213343-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213343-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213343-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213343-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213343-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213343-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213343-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213343-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213343-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213343-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213343-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213343-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213343-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213343-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213343-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213343-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-24 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213343-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213343-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A213343-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A213343-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A213343-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A213343-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-24 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213343-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213343-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213343-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213343-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213343-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213343-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213343-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213343-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213343-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213343-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213343-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213343-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213343-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-24 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213343-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2020-01-24 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Methotrexate
Listing expiration 2026-12-31 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# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82804-136-30 Methotrexate 30 in 1 BOTTLE TABLET 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82804-136 METHOTREXATE TABLET [PROFICIENT RX LP] 1 Current NDC, 1 package rows 20240904_a76808f0-38a7-4b54-a4fb-3584f9058ae5.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Methotrexate METHOTREXATE Accord Healthcare Inc. 874c7f43-a3be-4236-89cc-24c44e3c5813 2026-05-27 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213343 application number: ANDA213343 Methotrexate METHOTREXATE Bryant Ranch Prepack 4741a44f-0d0b-4380-84f6-231a8d1560fb 2026-05-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213343 application number: ANDA213343 Methotrexate METHOTREXATE NuCare Pharmaceuticals, Inc. 50b2cfc7-dfe4-4406-e063-6294a90a2527 2026-04-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213343 application number: ANDA213343 Methotrexate METHOTREXATE Coupler LLC 2f20d43e-a4b3-a839-e063-6394a90ace38 2025-02-27 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213343 application number: ANDA213343 Methotrexate METHOTREXATE Proficient Rx LP a76808f0-38a7-4b54-a4fb-3584f9058ae5 2024-08-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 213343 application number: ANDA213343 ndc (product): 82804-136
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82804-136-30 82804013630 30 TABLET in 1 BOTTLE (82804-136-30) 30 tablet 2024-08-28 No No Current