methotrexate

Generic: methotrexate

Labeler: accord healthcare, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methotrexate
Generic Name methotrexate
Labeler accord healthcare, inc.
Dosage Form INJECTION
Routes
INTRA-ARTERIAL INTRAMUSCULAR INTRATHECAL INTRAVENOUS
Active Ingredients

methotrexate 25 mg/mL

Manufacturer
Accord Healthcare, Inc.

Identifiers & Regulatory

Product NDC 16729-277
Product ID 16729-277_2bae3cfe-7aa0-c14c-e063-6294a90a19f4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040716
Listing Expiration 2026-12-31
Marketing Start 2014-03-07

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 16729277
Hyphenated Format 16729-277

Supplemental Identifiers

RxCUI
1655956 1655959 1655960
UPC
0316729277037 0316729277358 0316729277303
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 ANDA040716 (source: ndc)
Routes
INTRA-ARTERIAL INTRAMUSCULAR INTRATHECAL INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 25 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (16729-277-03) / 10 mL in 1 VIAL
  • 1 VIAL in 1 CARTON (16729-277-30) / 2 mL in 1 VIAL
  • 1 VIAL in 1 CARTON (16729-277-35) / 40 mL in 1 VIAL
source: ndc

Packages (3)

16729-277-03 1 VIAL in 1 CARTON (16729-277-03) / 10 mL in 1 VIAL 16729-277-30 1 VIAL in 1 CARTON (16729-277-30) / 2 mL in 1 VIAL 16729-277-35 1 VIAL in 1 CARTON (16729-277-35) / 40 mL in 1 VIAL

Ingredients (1)

methotrexate (25 mg/mL)

Linked Drug Pages (1)

Methotrexate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRA-ARTERIAL", "INTRAMUSCULAR", "INTRATHECAL", "INTRAVENOUS"], "spl_id": "2bae3cfe-7aa0-c14c-e063-6294a90a19f4", "openfda": {"nui": ["N0000175584", "N0000000111"], "upc": ["0316729277037", "0316729277358", "0316729277303"], "unii": ["YL5FZ2Y5U1"], "rxcui": ["1655956", "1655959", "1655960"], "spl_set_id": ["dd035a9f-cd40-4314-b9d8-2294b8a924e2"], "pharm_class_epc": ["Folate Analog Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Folic Acid Metabolism Inhibitors [MoA]"], "manufacturer_name": ["Accord Healthcare, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (16729-277-03)  / 10 mL in 1 VIAL", "package_ndc": "16729-277-03", "marketing_start_date": "20140307"}, {"sample": false, "description": "1 VIAL in 1 CARTON (16729-277-30)  / 2 mL in 1 VIAL", "package_ndc": "16729-277-30", "marketing_start_date": "20140307"}, {"sample": false, "description": "1 VIAL in 1 CARTON (16729-277-35)  / 40 mL in 1 VIAL", "package_ndc": "16729-277-35", "marketing_start_date": "20140307"}], "brand_name": "Methotrexate", "product_id": "16729-277_2bae3cfe-7aa0-c14c-e063-6294a90a19f4", "dosage_form": "INJECTION", "pharm_class": ["Folate Analog Metabolic Inhibitor [EPC]", "Folic Acid Metabolism Inhibitors [MoA]"], "product_ndc": "16729-277", "generic_name": "Methotrexate", "labeler_name": "Accord Healthcare, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methotrexate", "active_ingredients": [{"name": "METHOTREXATE", "strength": "25 mg/mL"}], "application_number": "ANDA040716", "marketing_category": "ANDA", "marketing_start_date": "20140307", "listing_expiration_date": "20261231"}