Caspofungin Acetate
NDC 47781-613
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
Caspofungin Acetate is a ANDA-approved product labeled by Alvogen Inc.. Caspofungin is used to treat a variety of fungal infections. It is supplied as a product. This product entry covers the primary NDC 47781-613 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
47781-613
Proprietary Name:
Caspofungin Acetate
Product Type: [3]
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
47781
HCPCS Code:
J0637
- INJECTION, CASPOFUNGIN ACETATE, 5 MG
FDA Application Number: [6]
ANDA207092
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
12-01-2017
End Marketing Date: [10]
10-01-2021
Listing Expiration Date: [11]
10-01-2021
Exclude Flag: [12]
D
Code Structure Chart
Patient Education
Caspofungin Injection
Caspofungin injection is used in adults and children 3 months of age and older to treat yeast infections in the blood, stomach, lungs, and esophagus (tube that connects the throat to the stomach.) and certain fungal infections that could not be treated successfully with other medications. It is also used to treat serious fungal infections in people with a weakened ability to fight infection. Caspofungin injection is in a class of antifungal medications called echinocandins. It works by slowing the growth of fungi that cause infection.
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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
