NDC 59088-770 Trilociclo

Triamcinolone Acetonide, Ciclopirox

NDC Product Code 59088-770

NDC 59088-770-00

Package Description: 1 KIT in 1 CARTON * 80 g in 1 TUBE (52565-014-80) * 1 BOTTLE, WITH APPLICATOR in 1 CARTON (45802-141-67) > 6.6 mL in 1 BOTTLE, WITH APPLICATOR

NDC Product Information

Trilociclo with NDC 59088-770 is a a human prescription drug product labeled by Puretek Corporation. The generic name of Trilociclo is triamcinolone acetonide, ciclopirox. The product's dosage form is kit and is administered via topical form.

Labeler Name: Puretek Corporation

Dosage Form: Kit - A packaged collection of related material.

Product Type: Human Prescription Drug 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.

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Puretek Corporation
Labeler Code: 59088
Marketing Category: UNAPPROVED DRUG OTHER - 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.

Start Marketing Date: 12-15-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

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