Home NDC 46708-711 METHOTREXATE
Product NDC 46708-711
11-digit product format 467080711
Labeler code 46708
Product ID 46708-711_e98b2abd-8068-482e-9ce3-1ab262f0838e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name methotrexate
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Alembic Pharmaceuticals Limited
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A220225-001 METHOTREXATE SODIUM METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION AP 2026-04-15 A220225-002 METHOTREXATE SODIUM METHOTREXATE SODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION AP 2026-04-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 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 A220225-001 METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION AP 2026-04-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A220225-002 METHOTREXATE SODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION AP 2026-04-15 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220225-001 METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION AP 2026-04-15 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220225-002 METHOTREXATE SODIUM EQ 1GM BASE/40ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION AP 2026-04-15 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-18 06:07:40 2026-07 A220225-001 AP 1 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A220225-002 AP 1 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220225-001 AP 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220225-002 AP 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base METHOTREXATE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHOTREXATE SODIUM 25 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3IG1E710ZN Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1655956 Internal RxNorm lookup 1946772 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 46708-711-01 METHOTREXATE 2 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 2 1 46708-711-05 METHOTREXATE 5 in 1 CARTON INJECTION, SOLUTION 5 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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 46708-711-01 46708071101 2 mL in 1 VIAL, MULTI-DOSE 2 ml Historical 46708-711-05 46708071105 5 VIAL, MULTI-DOSE in 1 CARTON (46708-711-05) / 2 mL in 1 VIAL, MULTI-DOSE (46708-711-01) 2026-04-15 No No Current