pemetrexed

Generic: pemetrexed disodium

Labeler: shilpa medicare limited
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name pemetrexed
Generic Name pemetrexed disodium
Labeler shilpa medicare limited
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

pemetrexed disodium hemipentahydrate 500 mg/50mL

Manufacturer
Shilpa Medicare Limited

Identifiers & Regulatory

Product NDC 63759-3049
Product ID 63759-3049_b0e3847a-fdcf-405c-823c-180fa8dad9c2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA215179
Listing Expiration 2026-12-31
Marketing Start 2024-01-01

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 637593049
Hyphenated Format 63759-3049

Supplemental Identifiers

RxCUI
2637958 2637966 2637968
UPC
0363759304912 0363759304813 0363759305018
UNII
F4GSH45R4C

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 pemetrexed (source: ndc)
Generic Name pemetrexed disodium (source: ndc)
Application Number NDA215179 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/50mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (63759-3049-1) / 50 mL in 1 VIAL
source: ndc

Packages (1)

63759-3049-1 1 VIAL in 1 CARTON (63759-3049-1) / 50 mL in 1 VIAL

Ingredients (1)

pemetrexed disodium hemipentahydrate (500 mg/50mL)

Linked Drug Pages (1)

Pemetrexed ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "b0e3847a-fdcf-405c-823c-180fa8dad9c2", "openfda": {"upc": ["0363759304912", "0363759304813", "0363759305018"], "unii": ["F4GSH45R4C"], "rxcui": ["2637958", "2637966", "2637968"], "spl_set_id": ["fe432994-e61b-4a87-8c98-cc20b847d0fe"], "manufacturer_name": ["Shilpa Medicare Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (63759-3049-1)  / 50 mL in 1 VIAL", "package_ndc": "63759-3049-1", "marketing_start_date": "20240101"}], "brand_name": "Pemetrexed", "product_id": "63759-3049_b0e3847a-fdcf-405c-823c-180fa8dad9c2", "dosage_form": "INJECTION", "pharm_class": ["Folate Analog Metabolic Inhibitor [EPC]", "Folic Acid Metabolism Inhibitors [MoA]"], "product_ndc": "63759-3049", "generic_name": "Pemetrexed disodium", "labeler_name": "Shilpa Medicare Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pemetrexed", "active_ingredients": [{"name": "PEMETREXED DISODIUM HEMIPENTAHYDRATE", "strength": "500 mg/50mL"}], "application_number": "NDA215179", "marketing_category": "NDA", "marketing_start_date": "20240101", "listing_expiration_date": "20261231"}