FDA.reportPublic FDA data

METHOTREXATE

Product NDC
62332-711
11-digit product format
623320711
Labeler code
62332
Product ID
62332-711_91ce9c78-370f-49a1-ae22-428bdddb389f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methotrexate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA220225
Marketing category
ANDA
Marketing start
2026-04-15
Substance
METHOTREXATE SODIUM
Active strength
25 mg/mL
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 42.

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
A220225-001METHOTREXATE SODIUMMETHOTREXATE SODIUMEQ 50MG BASE/2ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2026-04-15
A220225-002METHOTREXATE SODIUMMETHOTREXATE SODIUMEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2026-04-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A220225-001AP
A220225-002AP

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A220225-001METHOTREXATE SODIUMEQ 50MG BASE/2ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2026-04-15caaa826d4ba7…
2026-08-18 06:07:402026-07A220225-002METHOTREXATE SODIUMEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2026-04-15caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220225-001METHOTREXATE SODIUMEQ 50MG BASE/2ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2026-04-15a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220225-002METHOTREXATE SODIUMEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2026-04-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A220225-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A220225-002AP1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220225-001AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220225-002AP1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHOTREXATE SODIUM25 mg/mL

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1655956Internal RxNorm lookup
1946772Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a63364d5-4dfa-49d7-8a5e-c8959ae1d37aAvailable 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
62332-711-01METHOTREXATE2 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION24
62332-711-05METHOTREXATE5 in 1 CARTONINJECTION, SOLUTION54

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
METHOTREXATEMETHOTREXATEAlembic Pharmaceuticals Inc.a63364d5-4dfa-49d7-8a5e-c8959ae1d37a2026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 220225
application number: ANDA220225
ndc (product): 62332-711
METHOTREXATEMETHOTREXATEAlembic Pharmaceuticals Limitede98b2abd-8068-482e-9ce3-1ab262f0838e2026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 220225
application number: ANDA220225

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1655956methotrexate 1 GM in 40 ML InjectionPSNa63364d5-4dfa-49d7-8a5e-c8959ae1d37a4
1946772methotrexate 25 MG/mL Injectable SolutionPSNa63364d5-4dfa-49d7-8a5e-c8959ae1d37a4
165595640 ML methotrexate 25 MG/ML InjectionSCDa63364d5-4dfa-49d7-8a5e-c8959ae1d37a4
1946772methotrexate 25 MG/ML Injectable SolutionSCDa63364d5-4dfa-49d7-8a5e-c8959ae1d37a4
1946772methotrexate (as methotrexate sodium) 25 MG/ML Injectable SolutionSYa63364d5-4dfa-49d7-8a5e-c8959ae1d37a4
1655956methotrexate 1 GM per 40 ML InjectionSYa63364d5-4dfa-49d7-8a5e-c8959ae1d37a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62332-711-01623320711012 mL in 1 VIAL, MULTI-DOSE2 mlHistorical
62332-711-05623320711055 VIAL, MULTI-DOSE in 1 CARTON (62332-711-05) / 2 mL in 1 VIAL, MULTI-DOSE (62332-711-01) 2026-04-15NoNoCurrent