0527-1729 NDC - COCAINE HYDROCHLORIDE

Drug Information

Product NDC: 0527-1729

Proprietary Name: Cocaine Hydrochloride

Non Proprietary Name: Cocaine Hydrochloride

Active Ingredient(s):
  • 100 mg/mL COCAINE HYDROCHLORIDE


Administration Route(s): TOPICAL

Dosage Form(s): SOLUTION

Labeler Information

Labeler Name: Lannett Company, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number:
Marketing Category: UNAPPROVED DRUG OTHER
Start Marketing Date:12/1/2008
DEA Schedule:CII

Package Information

No. Package Code Package Description Billing Unit
10527-1729-7310 mL in 1 BOTTLE (0527-1729-73)
20527-1729-744 mL in 1 BOTTLE, GLASS (0527-1729-74)ML

NDC Record

Field Name Field Value Definition
PRODUCT NDC0527-1729The 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 NAMECocaine HydrochlorideThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMECocaine HydrochlorideThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMESOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMETOPICALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE12/1/2008This is the date that the labeler indicates was the start of its marketing of the drug product.
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 NAMELannett Company, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMECOCAINE HYDROCHLORIDEThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH100 
ACTIVE INGRED UNITmg/mL 
DEA SCHEDULECIIThis is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.

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This page was last updated on: 7/3/2018