Methotrexate Sodium

Product NDC
66758-040
11-digit product format
667580040
Labeler code
66758
Product ID
66758-040_b4c82062-08eb-482e-ba9d-6423ad032a98
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methotrexate Sodium
Dosage form
INJECTION, SOLUTION
Route
INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS
Labeler
Sandoz Inc
Application
ANDA090039
Marketing category
ANDA
Marketing start
2009-06-01
Marketing end
0000-00-00
Substance
METHOTREXATE SODIUM
Active strength
25 mg/mL
Pharmacologic classes
Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct66758-040DDiscontinued by firm2026-10-16
excluded packagepackage66758-04066758-040-02DDiscontinued by firm2026-10-16
excluded packagepackage66758-04066758-040-08DDiscontinued by firm2026-10-16

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 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66758-040-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66758-040-08d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66758-040-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66758-040-08f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66758-040-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66758-040-082ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66758-040-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66758-040-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66758-040-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66758-040-08cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66758-040-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66758-040-08cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66758-040-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66758-040-08302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66758-040-02ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66758-040-08ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66758-040-020efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66758-040-080efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66758-040-02ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66758-040-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage66758-040-02367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage66758-040-08367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66758-040-02557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66758-040-08557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090039-001METHOTREXATE SODIUM PRESERVATIVE FREEMETHOTREXATE SODIUMEQ 50MG BASE/2ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2009-03-31
A090039-002METHOTREXATE SODIUM PRESERVATIVE FREEMETHOTREXATE SODIUMEQ 250MG BASE/10ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2009-03-31

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 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A090039-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 50MG BASE/2ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2009-03-31c2088c7a36db…
2026-10-15 13:18:302026-09A090039-002METHOTREXATE SODIUM PRESERVATIVE FREEEQ 250MG BASE/10ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2009-03-31c2088c7a36db…
2026-09-14 22:38:342026-08A090039-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 50MG BASE/2ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2009-03-3184e616aacf4f…
2026-09-14 22:38:342026-08A090039-002METHOTREXATE SODIUM PRESERVATIVE FREEEQ 250MG BASE/10ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2009-03-3184e616aacf4f…
2026-08-18 06:07:402026-07A090039-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 50MG BASE/2ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2009-03-31caaa826d4ba7…
2026-08-18 06:07:402026-07A090039-002METHOTREXATE SODIUM PRESERVATIVE FREEEQ 250MG BASE/10ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2009-03-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090039-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 50MG BASE/2ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2009-03-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090039-002METHOTREXATE SODIUM PRESERVATIVE FREEEQ 250MG BASE/10ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2009-03-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090039-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 50MG BASE/2ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2009-03-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090039-002METHOTREXATE SODIUM PRESERVATIVE FREEEQ 250MG BASE/10ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2009-03-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090039-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 50MG BASE/2ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2009-03-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090039-002METHOTREXATE SODIUM PRESERVATIVE FREEEQ 250MG BASE/10ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2009-03-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090039-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 50MG BASE/2ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2009-03-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090039-002METHOTREXATE SODIUM PRESERVATIVE FREEEQ 250MG BASE/10ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2009-03-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090039-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 50MG BASE/2ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2009-03-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090039-002METHOTREXATE SODIUM PRESERVATIVE FREEEQ 250MG BASE/10ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2009-03-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090039-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 50MG BASE/2ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2009-03-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090039-002METHOTREXATE SODIUM PRESERVATIVE FREEEQ 250MG BASE/10ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2009-03-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090039-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 50MG BASE/2ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2009-03-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090039-002METHOTREXATE SODIUM PRESERVATIVE FREEEQ 250MG BASE/10ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2009-03-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090039-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 50MG BASE/2ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2009-03-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090039-002METHOTREXATE SODIUM PRESERVATIVE FREEEQ 250MG BASE/10ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2009-03-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090039-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 50MG BASE/2ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2009-03-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090039-002METHOTREXATE SODIUM PRESERVATIVE FREEEQ 250MG BASE/10ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2009-03-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090039-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 50MG BASE/2ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2009-03-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A090039-002METHOTREXATE SODIUM PRESERVATIVE FREEEQ 250MG BASE/10ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2009-03-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090039-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 50MG BASE/2ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2009-03-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090039-002METHOTREXATE SODIUM PRESERVATIVE FREEEQ 250MG BASE/10ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2009-03-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090039-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 50MG BASE/2ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2009-03-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090039-002METHOTREXATE SODIUM PRESERVATIVE FREEEQ 250MG BASE/10ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2009-03-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090039-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 50MG BASE/2ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2009-03-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090039-002METHOTREXATE SODIUM PRESERVATIVE FREEEQ 250MG BASE/10ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2009-03-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090039-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 50MG BASE/2ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2009-03-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090039-002METHOTREXATE SODIUM PRESERVATIVE FREEEQ 250MG BASE/10ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2009-03-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090039-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 50MG BASE/2ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2009-03-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090039-002METHOTREXATE SODIUM PRESERVATIVE FREEEQ 250MG BASE/10ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2009-03-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090039-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 50MG BASE/2ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2009-03-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090039-002METHOTREXATE SODIUM PRESERVATIVE FREEEQ 250MG BASE/10ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2009-03-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090039-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 50MG BASE/2ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2009-03-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090039-002METHOTREXATE SODIUM PRESERVATIVE FREEEQ 250MG BASE/10ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2009-03-314b0b4de00fa7…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090039-001AP187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090039-002AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A090039-001AP15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A090039-002AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090039-001AP18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A090039-002AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090039-001AP1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A090039-002AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090039-001AP13f01610625f2…
2019-12-14 00:12 UTC2019-12A090039-002AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A090039-001AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09A090039-002AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090039-001AP1ea99ee380514…
2019-07-19 19:46 UTC2019-07A090039-002AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090039-001AP16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090039-002AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090039-001AP11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A090039-002AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090039-001AP1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A090039-002AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090039-001AP1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090039-002AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090039-001AP19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090039-002AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090039-001AP1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090039-002AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090039-001AP13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090039-002AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090039-001AP1053a50430f4f…
2023-05-13 08:27 UTC2023-05A090039-002AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090039-001AP13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A090039-002AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090039-001AP13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090039-002AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090039-001AP1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A090039-002AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090039-001AP1e64feba35796…
2022-09-29 23:25 UTC2022-09A090039-002AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090039-001AP1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090039-002AP1cb3db0bc1861…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66758-040-02ML - Milliliter66758-0400bbd34ec-db1f-4363-a37f-6b89c9dd503a12012-07-24
66758-040-08ML - Milliliter66758-040730b05bb-1b74-48fa-975f-1675b90f107712012-07-24