pemetrexed

Generic: pemetrexed disodium

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

Drug Facts

Product Profile

Brand Name pemetrexed
Generic Name pemetrexed disodium
Labeler meitheal pharmaceuticals inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

pemetrexed disodium heptahydrate 100 mg/4.2mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-145
Product ID 71288-145_b369ac27-0118-4e53-be05-c9ba2dbf6875
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215479
Listing Expiration 2026-12-31
Marketing Start 2022-12-13

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 71288145
Hyphenated Format 71288-145

Supplemental Identifiers

RxCUI
1728072 1728077 2601728 2602136
UNII
9T47E4OM16

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 ANDA215479 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/4.2mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-145-10) / 4.2 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

71288-145-10 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-145-10) / 4.2 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

pemetrexed disodium heptahydrate (100 mg/4.2mL)

Linked Drug Pages (1)

Pemetrexed ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "b369ac27-0118-4e53-be05-c9ba2dbf6875", "openfda": {"unii": ["9T47E4OM16"], "rxcui": ["1728072", "1728077", "2601728", "2602136"], "spl_set_id": ["b185f459-5489-4e18-8521-1686b5d16f67"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-145-10)  / 4.2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "71288-145-10", "marketing_start_date": "20221213"}], "brand_name": "Pemetrexed", "product_id": "71288-145_b369ac27-0118-4e53-be05-c9ba2dbf6875", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Folate Analog Metabolic Inhibitor [EPC]", "Folic Acid Metabolism Inhibitors [MoA]"], "product_ndc": "71288-145", "generic_name": "Pemetrexed disodium", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pemetrexed", "active_ingredients": [{"name": "PEMETREXED DISODIUM HEPTAHYDRATE", "strength": "100 mg/4.2mL"}], "application_number": "ANDA215479", "marketing_category": "ANDA", "marketing_start_date": "20221213", "listing_expiration_date": "20261231"}