61383-091 NDC - UNDECYLENIC ACID

Drug Information

Product NDC: 61383-091

Proprietary Name:

Non Proprietary Name: UNDECYLENIC ACID

Active Ingredient(s):
  • 250 mg/mL UNDECYLENIC ACID


Administration Route(s):

Dosage Form(s): LIQUID

Labeler Information

Labeler Name: Dimensional Merchandising Inc.
Product Type: BULK INGREDIENT
FDA Application Number:
Marketing Category: DRUG FOR FURTHER PROCESSING
Start Marketing Date:7/30/2013
End Marketing Date:5/31/2024

Package Information

No. Package Code Package Description Billing Unit
161383-091-00270 TUBE, WITH APPLICATOR in 1 BOX (61383-091-00) / 1.7 mL in 1 TUBE, WITH APPLICATOR

NDC Record

Field Name Field Value Definition
PRODUCT NDC61383-091The 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 NAMEBULK INGREDIENTIndicates 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.
NON PROPRIETARY NAMEUNDECYLENIC ACIDThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMELIQUIDThe translation of the dosage form Code submitted by the firm.
START MARKETING DATE7/30/2013This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE5/31/2024This 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 NAMEDRUG FOR FURTHER PROCESSINGProduct 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 NAMEDimensional Merchandising Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEUNDECYLENIC ACIDAn 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.
ACTIVE NUMERATOR STRENGTH250 
ACTIVE INGRED UNITmg/mL 

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This page was last updated on: 5/3/2024