NDC 0781-3518 Pemetrexed
Pemetrexed Disodium Injection, Solution Intravenous - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
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Product Details
What is NDC 0781-3518?
What are the uses for Pemetrexed?
What are Pemetrexed Active Ingredients?
- PEMETREXED DISODIUM 100 mg/4mL - A guanine-derived ANTINEOPLASTIC AGENT that functions as a NUCLEIC ACID SYNTHESIS INHIBITOR through its binding to, and inhibition of, THYMIDYLATE SYNTHASE.
Which are Pemetrexed UNII Codes?
The UNII codes for the active ingredients in this product are:
- PEMETREXED DISODIUM (UNII: 2PKU919BA9)
- PEMETREXED (UNII: 04Q9AIZ7NO) (Active Moiety)
Which are Pemetrexed Inactive Ingredients UNII Codes?
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:
- SODIUM THIOSULFATE (UNII: HX1032V43M)
- HYDROCHLORIC ACID (UNII: QTT17582CB)
- SODIUM HYDROXIDE (UNII: 55X04QC32I)
- WATER (UNII: 059QF0KO0R)
- PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
What is the NDC to RxNorm Crosswalk for Pemetrexed?
- RxCUI: 2602363 - PEMEtrexed 500 MG in 20 ML Injection
- RxCUI: 2602363 - 20 ML pemetrexed 25 MG/ML Injection
- RxCUI: 2602363 - pemetrexed (as monohydrate) 500 MG per 20 ML Injection
- RxCUI: 2602365 - PEMEtrexed 1 GM in 40 ML Injection
- RxCUI: 2602365 - 40 ML pemetrexed 25 MG/ML Injection
Which are the Pharmacologic Classes for Pemetrexed?
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Patient Education
Pemetrexed Injection
Pemetrexed injection is used in combination with other chemotherapy medications as a first treatment for a certain type of non-small cell lung cancer (NSCLC) that has spread to nearby tissues or to other parts of the body. Pemetrexed injection is also used alone to treat NSCLC as ongoing treatment in people who have already received certain chemotherapy medications and whose cancer has not worsened and in people who could not be treated successfully with other chemotherapy medications. Pemetrexed injection is also in combination with another chemotherapy medication as a first treatment for malignant pleural mesothelioma (a type of cancer that affects the inside lining of the chest cavity) in people who cannot be treated with surgery. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by blocking the action of a certain substance in the body that may help cancer cells multiply.
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[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
[2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.
[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.
[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.
[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.
[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".