methotrexate

Generic: methotrexate

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methotrexate
Generic Name methotrexate
Labeler alembic pharmaceuticals limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

methotrexate sodium 2.5 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-730
Product ID 46708-730_ff55c573-dc84-4ff3-9d10-2b24c47dd679
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217552
Listing Expiration 2026-12-31
Marketing Start 2024-06-04

Pharmacologic Class

Classes
folate analog metabolic inhibitor [epc] folic acid metabolism inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708730
Hyphenated Format 46708-730

Supplemental Identifiers

RxCUI
105585
UPC
0346708730369
UNII
3IG1E710ZN

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name methotrexate (source: ndc)
Generic Name methotrexate (source: ndc)
Application Number ANDA217552 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (46708-730-31)
  • 36 TABLET in 1 BOTTLE (46708-730-36)
source: ndc

Packages (2)

46708-730-31 100 TABLET in 1 BOTTLE (46708-730-31) 46708-730-36 36 TABLET in 1 BOTTLE (46708-730-36)

Ingredients (1)

methotrexate sodium (2.5 mg/1)

Linked Drug Pages (1)

METHOTREXATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ff55c573-dc84-4ff3-9d10-2b24c47dd679", "openfda": {"upc": ["0346708730369"], "unii": ["3IG1E710ZN"], "rxcui": ["105585"], "spl_set_id": ["ff55c573-dc84-4ff3-9d10-2b24c47dd679"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (46708-730-31)", "package_ndc": "46708-730-31", "marketing_start_date": "20240604"}, {"sample": false, "description": "36 TABLET in 1 BOTTLE (46708-730-36)", "package_ndc": "46708-730-36", "marketing_start_date": "20240604"}], "brand_name": "METHOTREXATE", "product_id": "46708-730_ff55c573-dc84-4ff3-9d10-2b24c47dd679", "dosage_form": "TABLET", "pharm_class": ["Folate Analog Metabolic Inhibitor [EPC]", "Folic Acid Metabolism Inhibitors [MoA]"], "product_ndc": "46708-730", "generic_name": "METHOTREXATE", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METHOTREXATE", "active_ingredients": [{"name": "METHOTREXATE SODIUM", "strength": "2.5 mg/1"}], "application_number": "ANDA217552", "marketing_category": "ANDA", "marketing_start_date": "20240604", "listing_expiration_date": "20261231"}