Home NDC 63323-123 Methotrexate
Product NDC 63323-123
11-digit product format 633230123
Labeler code 63323
Product ID 63323-123_880c2caa-1b11-45ce-a54e-a3733da367f0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name METHOTREXATE SODIUM
Dosage form INJECTION, SOLUTION
Route INTRA-ARTERIAL; INTRAMUSCULAR; INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA040263
Marketing category ANDA
Marketing start 2001-09-10
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 2026-12-31
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 A040263-001 METHOTREXATE SODIUM METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION AP RS 1999-02-26 A040263-002 METHOTREXATE SODIUM METHOTREXATE SODIUM EQ 250MG BASE/10ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION 1999-02-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040263-001 AP
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 · 84 observed 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 A040263-001 METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION AP RS 1999-02-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040263-002 METHOTREXATE SODIUM EQ 250MG BASE/10ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION 1999-02-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040263-001 METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION AP RS 1999-02-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040263-002 METHOTREXATE SODIUM EQ 250MG BASE/10ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION 1999-02-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040263-001 METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION AP RS 1999-02-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040263-002 METHOTREXATE SODIUM EQ 250MG BASE/10ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION 1999-02-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040263-001 METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION AP RS 1999-02-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040263-002 METHOTREXATE SODIUM EQ 250MG BASE/10ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION 1999-02-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040263-001 METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION AP RS 1999-02-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040263-002 METHOTREXATE SODIUM EQ 250MG BASE/10ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION 1999-02-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040263-001 METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION AP RS 1999-02-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040263-002 METHOTREXATE SODIUM EQ 250MG BASE/10ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION 1999-02-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040263-001 METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION AP RS 1999-02-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040263-002 METHOTREXATE SODIUM EQ 250MG BASE/10ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION 1999-02-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040263-001 METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION AP RS 1999-02-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040263-002 METHOTREXATE SODIUM EQ 250MG BASE/10ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION 1999-02-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040263-001 METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION AP RS 1999-02-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040263-002 METHOTREXATE SODIUM EQ 250MG BASE/10ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION 1999-02-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040263-001 METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION AP RS 1999-02-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040263-002 METHOTREXATE SODIUM EQ 250MG BASE/10ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION 1999-02-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040263-001 METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION AP RS 1999-02-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040263-002 METHOTREXATE SODIUM EQ 250MG BASE/10ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION 1999-02-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040263-001 METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION AP RS 1999-02-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040263-002 METHOTREXATE SODIUM EQ 250MG BASE/10ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION 1999-02-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040263-001 METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION AP RS 1999-02-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040263-002 METHOTREXATE SODIUM EQ 250MG BASE/10ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION 1999-02-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040263-001 METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION AP RS 1999-02-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040263-002 METHOTREXATE SODIUM EQ 250MG BASE/10ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION 1999-02-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040263-001 METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION AP RS 1999-02-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A040263-002 METHOTREXATE SODIUM EQ 250MG BASE/10ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION 1999-02-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040263-001 METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION AP RS 1999-02-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040263-002 METHOTREXATE SODIUM EQ 250MG BASE/10ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION 1999-02-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040263-001 METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION AP RS 1999-02-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A040263-002 METHOTREXATE SODIUM EQ 250MG BASE/10ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION 1999-02-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040263-001 METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION AP RS 1999-02-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A040263-002 METHOTREXATE SODIUM EQ 250MG BASE/10ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION 1999-02-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040263-001 METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION AP RS 1999-02-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A040263-002 METHOTREXATE SODIUM EQ 250MG BASE/10ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION 1999-02-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040263-001 METHOTREXATE SODIUM EQ 50MG BASE/2ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION AP RS 1999-02-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A040263-002 METHOTREXATE SODIUM EQ 250MG BASE/10ML (EQ 25MG BASE/ML) INJECTABLE / INJECTION 1999-02-26 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Methotrexate
Listing expiration 2026-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 63323-123-10 Methotrexate 10 mL in 1 VIAL INJECTION, SOLUTION 10 6 63323-123-10 Methotrexate 1 in 1 CARTON INJECTION, SOLUTION 1 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METHOTREXATE SODIUM ACTIVE INGREDIENT 3IG1E710ZN METHOTREXATE (METHOTREXATE SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 3 METHOTREXATE ACTIVE MOIETY YL5FZ2Y5U1 METHOTREXATE (METHOTREXATE SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 3 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH METHOTREXATE (METHOTREXATE SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 3 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB METHOTREXATE (METHOTREXATE SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 3 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X METHOTREXATE (METHOTREXATE SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 3 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I METHOTREXATE (METHOTREXATE SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-123 METHOTREXATE (METHOTREXATE SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 6 Current NDC, Legacy NDC, 2 package rows 20210326_b585f621-f6c9-4735-ab61-bd1b401f3df0.zip
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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63323-123-10 63323012310 1 VIAL in 1 CARTON (63323-123-10) / 10 mL in 1 VIAL 1 vial 2001-09-10 0000-00-00 No No Current