59088-343 NDC - DERMACINRX LEXITRAL PHARMAPAK (DICLOFENAC SODIUM, CAPSAICIN)

Drug Information

Product NDC: 59088-343

Proprietary Name: DermacinRx Lexitral PharmaPak

Non Proprietary Name: diclofenac sodium, capsaicin

Active Ingredient(s):


Administration Route(s):

Dosage Form(s): KIT

Labeler Information

Labeler Name: PureTek Corporation
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number:
Marketing Category: UNAPPROVED DRUG OTHER
Start Marketing Date:11/6/2015
End Marketing Date:10/19/2028

Package Information

No. Package Code Package Description Billing Unit
159088-343-001 KIT in 1 CARTON (59088-343-00) * 1 CARTON in 1 KIT / 1 BOTTLE in 1 CARTON (59088-372-10) / 150 mL in 1 BOTTLE * 1 BOTTLE, PUMP in 1 KIT / 237 mL in 1 BOTTLE, PUMP (59088-310-16)ML

NDC Record

Field Name Field Value Definition
PRODUCT NDC59088-343The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates 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.
PROPRIETARY NAMEDermacinRx Lexitral PharmaPakThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEdiclofenac sodium, capsaicinThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEKITThe translation of the dosage form Code submitted by the firm.
START MARKETING DATE11/6/2015This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE10/19/2028This 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.
MARKETING CATEGORY NAMEUNAPPROVED DRUG OTHERProduct 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.
LABELER NAMEPureTek CorporationName of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 2/1/2023