Home NDC 68382-775 Methotrexate
Product NDC 68382-775
11-digit product format 683820775
Labeler code 68382
Product ID 68382-775_5d9b7269-19d4-4d2c-b252-f3ff759dffa5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methotrexate
Dosage form TABLET
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA207812
Marketing category ANDA
Marketing start 2017-02-09
Substance METHOTREXATE
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 2027-12-31
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 A207812-001 METHOTREXATE SODIUM METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2017-01-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207812-001 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 A207812-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2017-01-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207812-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2017-01-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207812-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2017-01-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207812-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2017-01-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207812-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2017-01-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207812-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2017-01-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207812-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2017-01-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207812-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2017-01-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207812-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2017-01-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207812-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2017-01-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207812-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2017-01-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207812-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2017-01-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207812-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2017-01-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207812-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2017-01-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207812-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2017-01-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207812-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2017-01-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207812-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2017-01-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207812-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2017-01-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207812-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2017-01-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207812-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2017-01-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207812-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2017-01-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207812-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2017-01-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207812-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2017-01-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207812-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2017-01-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207812-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2017-01-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207812-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2017-01-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207812-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2017-01-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207812-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2017-01-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207812-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2017-01-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207812-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2017-01-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207812-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2017-01-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207812-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2017-01-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207812-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2017-01-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207812-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2017-01-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207812-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2017-01-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207812-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2017-01-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207812-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2017-01-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207812-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2017-01-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207812-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2017-01-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207812-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2017-01-13 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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHOTREXATE 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 YL5FZ2Y5U1 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 68382-775 METHOTREXATE TABLET [ZYDUS PHARMACEUTICALS USA INC.] 7 Current NDC, Legacy NDC, 7 package rows 20231110_948e0bab-6524-4b87-9853-1799d4415558.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.
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 68382-775-01 68382077501 100 TABLET in 1 BOTTLE (68382-775-01) 100 tablet 2017-02-09 0000-00-00 No No Current 68382-775-05 68382077505 500 TABLET in 1 BOTTLE (68382-775-05) 500 tablet 2017-02-09 0000-00-00 No No Current 68382-775-10 68382077510 1000 TABLET in 1 BOTTLE (68382-775-10) 1000 tablet 2017-02-09 0000-00-00 No No Current 68382-775-16 68382077516 90 TABLET in 1 BOTTLE (68382-775-16) 90 tablet 2017-02-09 0000-00-00 No No Current 68382-775-60 68382077560 36 TABLET in 1 BOTTLE (68382-775-60) 36 tablet 2017-02-09 0000-00-00 No No Current 68382-775-77 68382077577 100 BLISTER PACK in 1 CARTON (68382-775-77) / 1 TABLET in 1 BLISTER PACK 100 blister pack 2017-02-09 0000-00-00 No No Current