Home NDC 51079-670 Methotrexate
Product NDC 51079-670
11-digit product format 510790670
Labeler code 51079
Product ID 51079-670_3a866716-12c5-4380-e063-6394a90ae975
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name methotrexate
Dosage form TABLET
Route ORAL
Labeler Mylan Institutional Inc.
Application ANDA081235
Marketing category ANDA
Marketing start 1995-07-13
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 A081235-001 METHOTREXATE SODIUM METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1992-05-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A081235-001 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.
Product history page 1 of 2 · 42 observed 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 A081235-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1992-05-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A081235-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1992-05-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A081235-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1992-05-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A081235-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1992-05-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A081235-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1992-05-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A081235-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1992-05-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A081235-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1992-05-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A081235-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1992-05-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A081235-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1992-05-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A081235-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1992-05-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A081235-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1992-05-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A081235-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1992-05-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A081235-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1992-05-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A081235-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1992-05-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A081235-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1992-05-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A081235-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1992-05-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A081235-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1992-05-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A081235-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1992-05-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A081235-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1992-05-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A081235-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1992-05-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A081235-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1992-05-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A081235-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1992-05-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A081235-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1992-05-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A081235-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1992-05-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A081235-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1992-05-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A081235-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1992-05-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A081235-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1992-05-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A081235-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1992-05-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A081235-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1992-05-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A081235-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1992-05-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A081235-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1992-05-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A081235-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1992-05-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A081235-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1992-05-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A081235-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1992-05-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A081235-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1992-05-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A081235-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1992-05-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A081235-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1992-05-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A081235-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1992-05-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A081235-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1992-05-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A081235-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1992-05-15 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 51079-670-01 Methotrexate 1 in 1 BLISTER PACK TABLET 1 20 51079-670-05 Methotrexate 20 in 1 CARTON TABLET 20 20
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51079-670 METHOTREXATE TABLET [MYLAN INSTITUTIONAL INC.] 19 Current NDC, Legacy NDC, 2 package rows 20241004_8df0780e-0fbd-4ab8-80b0-7a5eaa08ec0a.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 Bryant Ranch Prepack 0b54b5c4-2466-4f85-b9a0-ad93ec4a06a1 2026-06-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 081235 application number: ANDA081235 Methotrexate METHOTREXATE Mylan Pharmaceuticals Inc. 70c09984-2b36-424f-8b27-3fd0cd4e833d 2026-05-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 081235 application number: ANDA081235 Methotrexate METHOTREXATE Golden State Medical Supply, Inc. 6f14ced9-c16b-905a-e053-2a91aa0a031e 2026-04-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 081235 application number: ANDA081235 Methotrexate METHOTREXATE Safecor Health LLC f177e6fa-c482-432d-8208-937468ab3f10 2026-01-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 081235 application number: ANDA081235 Methotrexate METHOTREXATE Mylan Institutional Inc. 8df0780e-0fbd-4ab8-80b0-7a5eaa08ec0a 2025-07-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 081235 application number: ANDA081235 ndc (product): 51079-670
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51079-670-01 51079067001 1 in 1 BLISTER PACK Historical 51079-670-05 51079067005 20 BLISTER PACK in 1 CARTON (51079-670-05) / 1 TABLET in 1 BLISTER PACK (51079-670-01) 20 blister pack 1995-07-13 0000-00-00 No No Current