Home NDC 0143-9367 Methotrexate
Product NDC 0143-9367
11-digit product format 001439367
Labeler code 0143
Product ID 0143-9367_7950579c-084b-472b-a7ce-f342691aff97
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methotrexate
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA040632
Marketing category ANDA
Marketing start 2005-09-06
Substance METHOTREXATE
Active strength 1 g/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 A040632-001 METHOTREXATE SODIUM PRESERVATIVE FREE METHOTREXATE SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-08-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040632-001 AP
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 A040632-001 METHOTREXATE SODIUM PRESERVATIVE FREE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-08-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040632-001 METHOTREXATE SODIUM PRESERVATIVE FREE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-08-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040632-001 METHOTREXATE SODIUM PRESERVATIVE FREE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-08-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040632-001 METHOTREXATE SODIUM PRESERVATIVE FREE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-08-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040632-001 METHOTREXATE SODIUM PRESERVATIVE FREE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-08-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040632-001 METHOTREXATE SODIUM PRESERVATIVE FREE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-08-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040632-001 METHOTREXATE SODIUM PRESERVATIVE FREE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-08-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040632-001 METHOTREXATE SODIUM PRESERVATIVE FREE EQ 1GM BASE/VIAL INJECTABLE / INJECTION AP RS 2005-08-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040632-001 METHOTREXATE SODIUM PRESERVATIVE FREE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 2005-08-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040632-001 METHOTREXATE SODIUM PRESERVATIVE FREE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 2005-08-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040632-001 METHOTREXATE SODIUM PRESERVATIVE FREE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 2005-08-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040632-001 METHOTREXATE SODIUM PRESERVATIVE FREE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 2005-08-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040632-001 METHOTREXATE SODIUM PRESERVATIVE FREE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 2005-08-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040632-001 METHOTREXATE SODIUM PRESERVATIVE FREE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 2005-08-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040632-001 METHOTREXATE SODIUM PRESERVATIVE FREE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 2005-08-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040632-001 METHOTREXATE SODIUM PRESERVATIVE FREE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 2005-08-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040632-001 METHOTREXATE SODIUM PRESERVATIVE FREE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 2005-08-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040632-001 METHOTREXATE SODIUM PRESERVATIVE FREE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 2005-08-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040632-001 METHOTREXATE SODIUM PRESERVATIVE FREE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 2005-08-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040632-001 METHOTREXATE SODIUM PRESERVATIVE FREE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 2005-08-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040632-001 METHOTREXATE SODIUM PRESERVATIVE FREE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 2005-08-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040632-001 METHOTREXATE SODIUM PRESERVATIVE FREE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 2005-08-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040632-001 METHOTREXATE SODIUM PRESERVATIVE FREE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 2005-08-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040632-001 METHOTREXATE SODIUM PRESERVATIVE FREE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 2005-08-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040632-001 METHOTREXATE SODIUM PRESERVATIVE FREE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 2005-08-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040632-001 METHOTREXATE SODIUM PRESERVATIVE FREE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 2005-08-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040632-001 METHOTREXATE SODIUM PRESERVATIVE FREE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 2005-08-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040632-001 METHOTREXATE SODIUM PRESERVATIVE FREE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 2005-08-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040632-001 METHOTREXATE SODIUM PRESERVATIVE FREE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 2005-08-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040632-001 METHOTREXATE SODIUM PRESERVATIVE FREE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 2005-08-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040632-001 METHOTREXATE SODIUM PRESERVATIVE FREE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 2005-08-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040632-001 METHOTREXATE SODIUM PRESERVATIVE FREE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 2005-08-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040632-001 METHOTREXATE SODIUM PRESERVATIVE FREE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 2005-08-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040632-001 METHOTREXATE SODIUM PRESERVATIVE FREE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 2005-08-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040632-001 METHOTREXATE SODIUM PRESERVATIVE FREE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 2005-08-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040632-001 METHOTREXATE SODIUM PRESERVATIVE FREE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 2005-08-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040632-001 METHOTREXATE SODIUM PRESERVATIVE FREE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 2005-08-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040632-001 METHOTREXATE SODIUM PRESERVATIVE FREE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 2005-08-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040632-001 METHOTREXATE SODIUM PRESERVATIVE FREE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 2005-08-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040632-001 METHOTREXATE SODIUM PRESERVATIVE FREE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 2005-08-12 e64feba35796…
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 1 g/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 311625 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 0143-9367-01 Methotrexate 1 in 1 BOX INJECTION, POWDER, LYOPHILIZED, 1 2 0143-9367-01 Methotrexate 1 in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9367 METHOTREXATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 2 Current NDC, Legacy NDC, 2 package rows 20240906_8593f7fc-eabe-44ae-bb05-b3d7d408e4f7.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 · 2 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 0143-9367-01 00143936701 1 VIAL in 1 BOX (0143-9367-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL 1 vial 2005-09-06 0000-00-00 No No Current