pemetrexed

Generic: pemetrexed

Labeler: teva pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name pemetrexed
Generic Name pemetrexed
Labeler teva pharmaceuticals, inc.
Dosage Form SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

pemetrexed monohydrate 25 mg/mL

Manufacturer
Teva Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0480-4516
Product ID 0480-4516_21155bd2-118e-4ce6-adb8-dddc69ae34c7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208419
Listing Expiration 2026-12-31
Marketing Start 2022-06-01

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 04804516
Hyphenated Format 0480-4516

Supplemental Identifiers

RxCUI
2602363 2602365 2602366
UNII
236Y2F7D9J

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 (source: ndc)
Application Number NDA208419 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 25 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (0480-4516-01) / 4 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0480-4516-01 1 VIAL, SINGLE-DOSE in 1 CARTON (0480-4516-01) / 4 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

pemetrexed monohydrate (25 mg/mL)

Linked Drug Pages (1)

Pemetrexed ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "21155bd2-118e-4ce6-adb8-dddc69ae34c7", "openfda": {"unii": ["236Y2F7D9J"], "rxcui": ["2602363", "2602365", "2602366"], "spl_set_id": ["8b660f68-b770-4e0a-b2f9-25e663deecc3"], "manufacturer_name": ["Teva Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (0480-4516-01)  / 4 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0480-4516-01", "marketing_start_date": "20220601"}], "brand_name": "Pemetrexed", "product_id": "0480-4516_21155bd2-118e-4ce6-adb8-dddc69ae34c7", "dosage_form": "SOLUTION, CONCENTRATE", "pharm_class": ["Folate Analog Metabolic Inhibitor [EPC]", "Folic Acid Metabolism Inhibitors [MoA]"], "product_ndc": "0480-4516", "generic_name": "Pemetrexed", "labeler_name": "Teva Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pemetrexed", "active_ingredients": [{"name": "PEMETREXED MONOHYDRATE", "strength": "25 mg/mL"}], "application_number": "NDA208419", "marketing_category": "NDA", "marketing_start_date": "20220601", "listing_expiration_date": "20261231"}