Home NDC 64850-330 Methotrexate Sodium
Product NDC 64850-330
11-digit product format 648500330
Labeler code 64850
Product ID 64850-330_030a6bcf-d482-4c98-9d27-423235cdb930
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methotrexate Sodium
Dosage form TABLET
Route ORAL
Labeler Elite Laboratories, Inc.
Application ANDA216453
Marketing category ANDA
Marketing start 2024-05-16
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 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216453-001 METHOTREXATE SODIUM METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2024-05-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216453-001 AB
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 A216453-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2024-05-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216453-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2024-05-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216453-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2024-05-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216453-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2024-05-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216453-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2024-05-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216453-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2024-05-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216453-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2024-05-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216453-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2024-05-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216453-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2024-05-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216453-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2024-05-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216453-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2024-05-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216453-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2024-05-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216453-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2024-05-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216453-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2024-05-16 1e350fbaab3a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216453-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 2024-05-16 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Methotrexate Sodium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHOTREXATE SODIUM 2.5 mg/1
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 105585 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 64850-330-01 Methotrexate Sodium 100 in 1 BOTTLE, PLASTIC TABLET 100 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64850-330 METHOTREXATE SODIUM TABLET [ELITE LABORATORIES, INC.] 2 Current NDC, 1 package rows 20240524_89c05ea3-3be1-46dd-b112-29c436fd7289.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 Sample Exclude flag Status 64850-330-01 64850033001 100 TABLET in 1 BOTTLE, PLASTIC (64850-330-01) 100 tablet 2024-05-16 No No Current