Methotrexate

Product NDC
48433-065
Requested package NDC
48433-065-05
11-digit product format
484330065
Labeler code
48433
Product ID
48433-065_49a1fdee-5587-e05a-e063-6294a90aebc5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methotrexate
Dosage form
TABLET
Route
ORAL
Labeler
Safecor Health LLC
Application
ANDA081235
Marketing category
ANDA
Marketing start
2026-01-19
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A081235-001METHOTREXATE SODIUMMETHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1992-05-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A081235-001AB

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A081235-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1992-05-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A081235-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1992-05-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A081235-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1992-05-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A081235-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1992-05-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A081235-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1992-05-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A081235-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1992-05-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A081235-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1992-05-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A081235-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1992-05-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A081235-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1992-05-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A081235-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1992-05-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A081235-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1992-05-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A081235-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1992-05-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A081235-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1992-05-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A081235-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1992-05-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A081235-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1992-05-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A081235-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1992-05-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A081235-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1992-05-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A081235-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1992-05-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A081235-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1992-05-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A081235-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1992-05-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A081235-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1992-05-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A081235-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1992-05-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A081235-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1992-05-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A081235-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1992-05-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A081235-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1992-05-153f01610625f2…
2019-09-15 20:21 UTC2019-09A081235-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1992-05-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A081235-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1992-05-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A081235-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1992-05-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A081235-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1992-05-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A081235-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1992-05-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A081235-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1992-05-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A081235-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1992-05-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A081235-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1992-05-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A081235-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1992-05-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A081235-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1992-05-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A081235-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1992-05-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A081235-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1992-05-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A081235-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1992-05-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A081235-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1992-05-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A081235-001METHOTREXATE SODIUMEQ 2.5MG BASETABLET / ORALAB1992-05-15cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A081235-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A081235-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A081235-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A081235-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A081235-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A081235-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A081235-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A081235-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A081235-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A081235-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A081235-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A081235-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A081235-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A081235-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A081235-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A081235-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A081235-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A081235-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A081235-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A081235-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A081235-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A081235-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A081235-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A081235-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A081235-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A081235-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A081235-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A081235-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A081235-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A081235-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A081235-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A081235-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A081235-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A081235-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A081235-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A081235-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A081235-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A081235-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A081235-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A081235-001AB1cb3db0bc1861…

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
f177e6fa-c482-432d-8208-937468ab3f10Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2eb9a854-4fbc-9bbe-3199-41fc1018a1f0Product name920250224
3082de91-569a-4d57-b379-acbf37f1d5c3Product name120210312
f76135bc-a210-42d9-851b-1b73cbaccdb3Product name120200511
423544b2-e325-49ee-8910-4c5dfe41906fProduct name120181120
c9fd924b-0a8d-4d53-bf70-11070e24e4ddProduct name220181120
ce1e7cc6-4850-4cb1-8dde-8010b2fbc359Product name120181120
eb454f54-2806-4c31-a08b-8dcb08261099Product name220181120
d9cebc09-c68d-46f5-bdcd-fd82e945cc27Product name120170705
16ba0c1e-2371-48a4-8b4c-a9a338dfe1f3Product name220160504
88514aea-9d58-4ed2-b135-9811fb14c8fbProduct name120141209
0eba90a2-1cca-7e7b-28a5-85a09e2bc9a4Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48433-065-01Methotrexate1 in 1 BLISTER PACKTABLET12
48433-065-05Methotrexate20 in 1 CARTONTABLET202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
48433-065-05EA - Each48433-0659323610b-703d-4b26-aa83-8eaef092205012026-05-22

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethotrexateMETHOTREXATEBryant Ranch Prepack0b54b5c4-2466-4f85-b9a0-ad93ec4a06a12026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 081235
application number: ANDA081235
MethotrexateMETHOTREXATEMylan Pharmaceuticals Inc.70c09984-2b36-424f-8b27-3fd0cd4e833d2026-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 081235
application number: ANDA081235
MethotrexateMETHOTREXATEGolden State Medical Supply, Inc.6f14ced9-c16b-905a-e053-2a91aa0a031e2026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 081235
application number: ANDA081235
MethotrexateMETHOTREXATESafecor Health LLCf177e6fa-c482-432d-8208-937468ab3f102026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 081235
application number: ANDA081235
ndc (package): 48433-065-05
ndc (product): 48433-065
ndc11 (package): 48433006505
MethotrexateMETHOTREXATEMylan Institutional Inc.8df0780e-0fbd-4ab8-80b0-7a5eaa08ec0a2025-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 081235
application number: ANDA081235

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
105585methotrexate 2.5 MG Oral TabletPSNf177e6fa-c482-432d-8208-937468ab3f102
105585methotrexate 2.5 MG Oral TabletSCDf177e6fa-c482-432d-8208-937468ab3f102
105585methotrexate 2.5 MG (as methotrexate sodium) Oral TabletSYf177e6fa-c482-432d-8208-937468ab3f102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
48433-065-054843300650520 BLISTER PACK in 1 CARTON (48433-065-05) / 1 TABLET in 1 BLISTER PACK (48433-065-01) 20 blister pack2026-01-19NoNoCurrent