Methotrexate

Product NDC
42291-594
11-digit product format
422910594
Labeler code
42291
Product ID
42291-594_9c5e2f29-a0f1-e9f0-e053-2995a90abf53
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methotrexate
Dosage form
TABLET
Route
ORAL
Labeler
AvKARE, Inc.
Application
ANDA081099
Marketing category
ANDA
Marketing start
2014-11-20
Marketing end
0000-00-00
Substance
METHOTREXATE SODIUM
Active strength
3 mg/1
Pharmacologic classes
Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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 · 24 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 packagepackage42291-594-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42291-594-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42291-594-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42291-594-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42291-594-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42291-594-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42291-594-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42291-594-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42291-594-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42291-594-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42291-594-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42291-594-01557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A081099-001METHOTREXATE SODIUMMETHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1990-10-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A081099-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A081099-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1990-10-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A081099-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1990-10-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A081099-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1990-10-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A081099-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1990-10-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A081099-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1990-10-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A081099-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1990-10-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A081099-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1990-10-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A081099-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1990-10-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A081099-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1990-10-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A081099-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1990-10-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A081099-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1990-10-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A081099-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1990-10-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A081099-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1990-10-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A081099-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1990-10-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A081099-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1990-10-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A081099-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1990-10-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A081099-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1990-10-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A081099-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1990-10-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A081099-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1990-10-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A081099-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1990-10-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A081099-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1990-10-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A081099-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1990-10-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A081099-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1990-10-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A081099-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1990-10-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A081099-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1990-10-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A081099-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1990-10-153f01610625f2…
2019-09-15 20:21 UTC2019-09A081099-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1990-10-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A081099-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1990-10-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A081099-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1990-10-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A081099-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1990-10-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A081099-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1990-10-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A081099-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1990-10-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A081099-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1990-10-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A081099-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1990-10-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A081099-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1990-10-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A081099-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1990-10-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A081099-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1990-10-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A081099-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1990-10-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A081099-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1990-10-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A081099-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1990-10-15e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A081099-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A081099-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A081099-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A081099-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A081099-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A081099-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A081099-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A081099-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A081099-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A081099-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A081099-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A081099-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A081099-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A081099-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A081099-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A081099-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A081099-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A081099-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A081099-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A081099-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A081099-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A081099-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A081099-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A081099-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A081099-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A081099-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A081099-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A081099-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A081099-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A081099-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A081099-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A081099-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A081099-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A081099-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A081099-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A081099-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A081099-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A081099-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A081099-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A081099-001AB1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Methotrexate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHOTREXATE SODIUM2.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3IG1E710ZNInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
105585Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
757d6cef-6696-7a1c-8074-01258aaa8bddAvailable on FDA.report

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-594-01EA - Each42291-59471378ec3-bc56-4bee-99f1-962f554ebc0a12015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHOTREXATE SODIUMACTIVE INGREDIENT3IG1E710ZNMETHOTREXATE (METHOTREXATE) TABLET [AVKARE, INC.]1
METHOTREXATEACTIVE MOIETYYL5FZ2Y5U1METHOTREXATE (METHOTREXATE) TABLET [AVKARE, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMETHOTREXATE (METHOTREXATE) TABLET [AVKARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETHOTREXATE (METHOTREXATE) TABLET [AVKARE, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETHOTREXATE (METHOTREXATE) TABLET [AVKARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHOTREXATE (METHOTREXATE) TABLET [AVKARE, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMETHOTREXATE (METHOTREXATE) TABLET [AVKARE, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3METHOTREXATE (METHOTREXATE) TABLET [AVKARE, INC.]1
SODIUM CARBONATE MONOHYDRATEINACTIVE INGREDIENT2A1Q1Q3557METHOTREXATE (METHOTREXATE) TABLET [AVKARE, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETHOTREXATE (METHOTREXATE) TABLET [AVKARE, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UMETHOTREXATE (METHOTREXATE) TABLET [AVKARE, INC.]1

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethotrexateMETHOTREXATEAvKARE757d6cef-6696-7a1c-8074-01258aaa8bdd2026-07-23Boxed warning, Adverse reactionsExact identifier
application applno (ANDA): 081099
application number: ANDA081099
ndc (product): 42291-594
MethotrexateMETHOTREXATETeva Pharmaceuticals USA, Inc.9b34b1d8-d125-41a2-9f6f-3fab67b573bd2026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 081099
application number: ANDA081099
MethotrexateMETHOTREXATEA-S Medication Solutions22e10810-16fb-4c84-bccf-972405b77ef82026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 081099
application number: ANDA081099
MethotrexateMETHOTREXATEBryant Ranch Prepacke6611304-4622-4b2e-9b94-57fbad023ae22024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 081099
application number: ANDA081099

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-594-0142291059401100 TABLET in 1 BOTTLE (42291-594-01) 100 tablet2014-11-200000-00-00NoNoCurrent