pemetrexed dipotassium

Generic: pemetrexed dipotassium

Labeler: avyxa pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name pemetrexed dipotassium
Generic Name pemetrexed dipotassium
Labeler avyxa pharma, llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

pemetrexed 100 mg/4mL

Manufacturer
Avyxa Pharma, LLC

Identifiers & Regulatory

Product NDC 83831-111
Product ID 83831-111_0c1baa15-83bb-45a0-a3ab-855a4fee9129
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA210661
Listing Expiration 2026-12-31
Marketing Start 2025-01-01

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 83831111
Hyphenated Format 83831-111

Supplemental Identifiers

RxCUI
1728072 1728077
UPC
0383831111016 0383831112013
UNII
04Q9AIZ7NO
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 pemetrexed dipotassium (source: ndc)
Generic Name pemetrexed dipotassium (source: ndc)
Application Number NDA210661 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/4mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (83831-111-01) / 4 mL in 1 VIAL
source: ndc

Packages (1)

83831-111-01 1 VIAL in 1 CARTON (83831-111-01) / 4 mL in 1 VIAL

Ingredients (1)

pemetrexed (100 mg/4mL)

Linked Drug Pages (1)

PEMETREXED DIPOTASSIUM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "0c1baa15-83bb-45a0-a3ab-855a4fee9129", "openfda": {"nui": ["N0000175584", "N0000000111"], "upc": ["0383831111016", "0383831112013"], "unii": ["04Q9AIZ7NO"], "rxcui": ["1728072", "1728077"], "spl_set_id": ["adc9ce4c-926a-4ee8-bd0d-d06fc89c17fc"], "pharm_class_epc": ["Folate Analog Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Folic Acid Metabolism Inhibitors [MoA]"], "manufacturer_name": ["Avyxa Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (83831-111-01)  / 4 mL in 1 VIAL", "package_ndc": "83831-111-01", "marketing_start_date": "20250101"}], "brand_name": "PEMETREXED DIPOTASSIUM", "product_id": "83831-111_0c1baa15-83bb-45a0-a3ab-855a4fee9129", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Folate Analog Metabolic Inhibitor [EPC]", "Folic Acid Metabolism Inhibitors [MoA]"], "product_ndc": "83831-111", "generic_name": "pemetrexed dipotassium", "labeler_name": "Avyxa Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PEMETREXED DIPOTASSIUM", "active_ingredients": [{"name": "PEMETREXED", "strength": "100 mg/4mL"}], "application_number": "NDA210661", "marketing_category": "NDA", "marketing_start_date": "20250101", "listing_expiration_date": "20261231"}