Home NDC 0054-4550 Methotrexate Sodium
Product NDC 0054-4550
11-digit product format 000544550
Labeler code 0054
Product ID 0054-4550_e0c12c0f-ae9c-4d79-8c27-b2ce3861f918
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methotrexate Sodium
Dosage form TABLET
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA040054
Marketing category ANDA
Marketing start 1994-08-01
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 2027-12-31
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0054-4550 0054-4550-15 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0054-4550 0054-4550-15 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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 A040054-001 METHOTREXATE SODIUM METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB RS 1994-08-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040054-001 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 A040054-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB RS 1994-08-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040054-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB RS 1994-08-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040054-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB RS 1994-08-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040054-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB RS 1994-08-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040054-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB RS 1994-08-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040054-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB RS 1994-08-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040054-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB RS 1994-08-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040054-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB RS 1994-08-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040054-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB RS 1994-08-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040054-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB RS 1994-08-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040054-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB RS 1994-08-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040054-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB RS 1994-08-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040054-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB RS 1994-08-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040054-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB RS 1994-08-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040054-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB RS 1994-08-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040054-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB RS 1994-08-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040054-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB RS 1994-08-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040054-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB RS 1994-08-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040054-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1994-08-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040054-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB RS 1994-08-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040054-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB RS 1994-08-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040054-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB RS 1994-08-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040054-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB RS 1994-08-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040054-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB RS 1994-08-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040054-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB RS 1994-08-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040054-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1994-08-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040054-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1994-08-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040054-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1994-08-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040054-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB RS 1994-08-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040054-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB RS 1994-08-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040054-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB RS 1994-08-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040054-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB RS 1994-08-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040054-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB RS 1994-08-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040054-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB RS 1994-08-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040054-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB RS 1994-08-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040054-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB RS 1994-08-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040054-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB RS 1994-08-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040054-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB RS 1994-08-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040054-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB RS 1994-08-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040054-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB RS 1994-08-01 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 Sodium
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# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0054-4550-15 Methotrexate Sodium 36 in 1 BOTTLE, PLASTIC TABLET 36 20 0054-4550-25 Methotrexate Sodium 100 in 1 BOTTLE, PLASTIC TABLET 100 20
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METHOTREXATE SODIUM ACTIVE INGREDIENT 3IG1E710ZN METHOTREXATE SODIUM TABLET [ROXANE LABORATORIES, INC] 8 METHOTREXATE ACTIVE MOIETY YL5FZ2Y5U1 METHOTREXATE SODIUM TABLET [ROXANE LABORATORIES, INC] 8 LACTOSE INACTIVE INGREDIENT J2B2A4N98G METHOTREXATE SODIUM TABLET [ROXANE LABORATORIES, INC] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METHOTREXATE SODIUM TABLET [ROXANE LABORATORIES, INC] 8 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I METHOTREXATE SODIUM TABLET [ROXANE LABORATORIES, INC] 8 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 METHOTREXATE SODIUM TABLET [ROXANE LABORATORIES, INC] 8 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ METHOTREXATE SODIUM TABLET [ROXANE LABORATORIES, INC] 8 METHOTREXATE SODIUM ACTIVE INGREDIENT 3IG1E710ZN METHOTREXATE SODIUM TABLET [BRYANT RANCH PREPACK] 2 METHOTREXATE ACTIVE MOIETY YL5FZ2Y5U1 METHOTREXATE SODIUM TABLET [BRYANT RANCH PREPACK] 2 LACTOSE INACTIVE INGREDIENT J2B2A4N98G METHOTREXATE SODIUM TABLET [BRYANT RANCH PREPACK] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METHOTREXATE SODIUM TABLET [BRYANT RANCH PREPACK] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I METHOTREXATE SODIUM TABLET [BRYANT RANCH PREPACK] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 METHOTREXATE SODIUM TABLET [BRYANT RANCH PREPACK] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ METHOTREXATE SODIUM TABLET [BRYANT RANCH PREPACK] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-4550 METHOTREXATE SODIUM TABLET [HIKMA PHARMACEUTICALS USA INC.] 17 Current NDC, Legacy NDC, 2 package rows 20240302_d71b1856-99d8-4a9e-9189-f87b6675f80a.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 · 1 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 0054-4550-15 00054455015 36 TABLET in 1 BOTTLE, PLASTIC (0054-4550-15) 36 tablet 1994-08-01 0000-00-00 No No Current 0054-4550-25 00054455025 100 TABLET in 1 BOTTLE, PLASTIC (0054-4550-25) 100 tablet 1994-08-01 0000-00-00 No No Current