Home NDC 71335-0782 Methotrexate
Product NDC 71335-0782
11-digit product format 713350782
Labeler code 71335
Product ID 71335-0782_c5595381-c3bc-43a4-9c65-0b68b454a891
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methotrexate
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA081099
Marketing category ANDA
Marketing start 1990-11-01
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A081099-001 METHOTREXATE SODIUM METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A081099-001 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 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-0782 METHOTREXATE TABLET [BRYANT RANCH PREPACK] 9 Current NDC, Legacy NDC, 8 package rows 20241004_e6611304-4622-4b2e-9b94-57fbad023ae2.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 AvKARE 757d6cef-6696-7a1c-8074-01258aaa8bdd 2026-07-23 Boxed warning, Adverse reactions Exact identifier application applno (ANDA): 081099 application number: ANDA081099 Methotrexate METHOTREXATE Teva Pharmaceuticals USA, Inc. 9b34b1d8-d125-41a2-9f6f-3fab67b573bd 2026-06-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 081099 application number: ANDA081099 Methotrexate METHOTREXATE A-S Medication Solutions 22e10810-16fb-4c84-bccf-972405b77ef8 2026-02-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 081099 application number: ANDA081099 Methotrexate METHOTREXATE Bryant Ranch Prepack e6611304-4622-4b2e-9b94-57fbad023ae2 2024-10-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 081099 application number: ANDA081099 ndc (product): 71335-0782
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 71335-0782-1 71335078201 30 TABLET in 1 BOTTLE (71335-0782-1) 30 tablet 2019-02-25 0000-00-00 No No Current 71335-0782-2 71335078202 12 TABLET in 1 BOTTLE (71335-0782-2) 12 tablet 2021-04-09 0000-00-00 No No Current 71335-0782-3 71335078203 20 TABLET in 1 BOTTLE (71335-0782-3) 20 tablet 2021-04-09 0000-00-00 No No Current 71335-0782-4 71335078204 100 TABLET in 1 BOTTLE (71335-0782-4) 100 tablet 2018-04-19 0000-00-00 No No Current 71335-0782-5 71335078205 36 TABLET in 1 BOTTLE (71335-0782-5) 36 tablet 2021-04-09 0000-00-00 No No Current 71335-0782-6 71335078206 24 TABLET in 1 BOTTLE (71335-0782-6) 24 tablet 2021-04-09 0000-00-00 No No Current 71335-0782-7 71335078207 90 TABLET in 1 BOTTLE (71335-0782-7) 90 tablet 2021-04-09 0000-00-00 No No Current 71335-0782-8 71335078208 4 TABLET in 1 BOTTLE (71335-0782-8) 4 tablet 2021-04-09 0000-00-00 No No Current