methotrexate

Generic: methotrexate

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methotrexate
Generic Name methotrexate
Labeler zydus pharmaceuticals usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

methotrexate 2.5 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-775
Product ID 68382-775_12e61f0c-901b-4891-9a52-0cf78ebe64b6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207812
Listing Expiration 2026-12-31
Marketing Start 2017-02-09

Pharmacologic Class

Established (EPC)
folate analog metabolic inhibitor [epc]
Mechanism of Action
folic acid metabolism inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68382775
Hyphenated Format 68382-775

Supplemental Identifiers

RxCUI
105585
UNII
YL5FZ2Y5U1
NUI
N0000175584 N0000000111

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 ANDA207812 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68382-775-01)
  • 500 TABLET in 1 BOTTLE (68382-775-05)
  • 1000 TABLET in 1 BOTTLE (68382-775-10)
  • 90 TABLET in 1 BOTTLE (68382-775-16)
  • 36 TABLET in 1 BOTTLE (68382-775-60)
  • 100 BLISTER PACK in 1 CARTON (68382-775-77) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (6)

68382-775-01 100 TABLET in 1 BOTTLE (68382-775-01) 68382-775-05 500 TABLET in 1 BOTTLE (68382-775-05) 68382-775-10 1000 TABLET in 1 BOTTLE (68382-775-10) 68382-775-16 90 TABLET in 1 BOTTLE (68382-775-16) 68382-775-60 36 TABLET in 1 BOTTLE (68382-775-60) 68382-775-77 100 BLISTER PACK in 1 CARTON (68382-775-77) / 1 TABLET in 1 BLISTER PACK

Ingredients (1)

methotrexate (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": "12e61f0c-901b-4891-9a52-0cf78ebe64b6", "openfda": {"nui": ["N0000175584", "N0000000111"], "unii": ["YL5FZ2Y5U1"], "rxcui": ["105585"], "spl_set_id": ["948e0bab-6524-4b87-9853-1799d4415558"], "pharm_class_epc": ["Folate Analog Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Folic Acid Metabolism Inhibitors [MoA]"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68382-775-01)", "package_ndc": "68382-775-01", "marketing_start_date": "20170209"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (68382-775-05)", "package_ndc": "68382-775-05", "marketing_start_date": "20170209"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (68382-775-10)", "package_ndc": "68382-775-10", "marketing_start_date": "20170209"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68382-775-16)", "package_ndc": "68382-775-16", "marketing_start_date": "20170209"}, {"sample": false, "description": "36 TABLET in 1 BOTTLE (68382-775-60)", "package_ndc": "68382-775-60", "marketing_start_date": "20170209"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (68382-775-77)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "68382-775-77", "marketing_start_date": "20170209"}], "brand_name": "Methotrexate", "product_id": "68382-775_12e61f0c-901b-4891-9a52-0cf78ebe64b6", "dosage_form": "TABLET", "pharm_class": ["Folate Analog Metabolic Inhibitor [EPC]", "Folic Acid Metabolism Inhibitors [MoA]"], "product_ndc": "68382-775", "generic_name": "Methotrexate", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methotrexate", "active_ingredients": [{"name": "METHOTREXATE", "strength": "2.5 mg/1"}], "application_number": "ANDA207812", "marketing_category": "ANDA", "marketing_start_date": "20170209", "listing_expiration_date": "20261231"}