69315-186 NDC - LEUCOVORIN CALCIUM

Drug Information

  • Product NDC: 69315-186
  • Proprietary Name: LEUCOVORIN CALCIUM
  • Non Proprietary Name: LEUCOVORIN CALCIUM
  • Active Ingredient(s): 15 mg/1 LEUCOVORIN CALCIUM
  • Administration Route(s): ORAL
  • Dosage Form(s): TABLET
  • Pharmacy Class(es): Folate Analog [EPC]; Folic Acid [CS]

Labeler Information

Field Name Field Value
Labeler Name: Leading Pharma, LLC
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA213929
Marketing Category: ANDA
Start Marketing Date:11/16/2020

Package Information

No. Package Code Package Description Billing Unit
169315-186-2424 TABLET in 1 BOTTLE (69315-186-24)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC69315-186The 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 NAMELEUCOVORIN CALCIUMThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMELEUCOVORIN CALCIUMThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLETThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe 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.
START MARKETING DATE11/16/2020The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
MARKETING CATEGORY NAMEANDAThis is the date that the labeler indicates was the start of its marketing of the drug product.
APPLICATION NUMBERANDA213929This 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.
LABELER NAMELeading Pharma, LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMELEUCOVORIN CALCIUMAn 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 STRENGTH15 
ACTIVE INGRED UNITmg/1 
PHARM CLASSESFolate Analog [EPC], Folic Acid [CS] 

Download Record

Download this NDC record record in Text format: Export

Download this NDC record record in Excel (CSV) format: Export

Download this NDC record record in XML format: Export

This page was last updated on: 5/9/2025

Previous Code
Next Code