axtle

Generic: pemetrexed

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

Drug Facts

Product Profile

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

pemetrexed 500 mg/20mL

Manufacturer
Avyxa Pharma, LLC

Identifiers & Regulatory

Product NDC 83831-132
Product ID 83831-132_6e125601-ebbb-4fe6-9d9e-80d093b12532
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 83831132
Hyphenated Format 83831-132

Supplemental Identifiers

RxCUI
1728072 1728077 2699339 2699341
UPC
0383831131014 0383831132011
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 axtle (source: ndc)
Generic Name pemetrexed (source: ndc)
Application Number NDA210661 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/20mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (83831-132-01) / 20 mL in 1 VIAL
source: ndc

Packages (1)

83831-132-01 1 VIAL in 1 CARTON (83831-132-01) / 20 mL in 1 VIAL

Ingredients (1)

pemetrexed (500 mg/20mL)

Linked Drug Pages (1)

AXTLE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "6e125601-ebbb-4fe6-9d9e-80d093b12532", "openfda": {"nui": ["N0000175584", "N0000000111"], "upc": ["0383831131014", "0383831132011"], "unii": ["04Q9AIZ7NO"], "rxcui": ["1728072", "1728077", "2699339", "2699341"], "spl_set_id": ["9582c46c-d8b0-44b7-a2ee-9c86f5e9b7b1"], "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 (83831-132-01)  / 20 mL in 1 VIAL", "package_ndc": "83831-132-01", "marketing_start_date": "20250101"}], "brand_name": "AXTLE", "product_id": "83831-132_6e125601-ebbb-4fe6-9d9e-80d093b12532", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Folate Analog Metabolic Inhibitor [EPC]", "Folic Acid Metabolism Inhibitors [MoA]"], "product_ndc": "83831-132", "generic_name": "pemetrexed", "labeler_name": "Avyxa Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AXTLE", "active_ingredients": [{"name": "PEMETREXED", "strength": "500 mg/20mL"}], "application_number": "NDA210661", "marketing_category": "NDA", "marketing_start_date": "20250101", "listing_expiration_date": "20261231"}