42806-833 NDC - BUSPIRONE HYDROCHLORIDE

Drug Information

  • Product NDC: 42806-833
  • Proprietary Name: Buspirone Hydrochloride
  • Non Proprietary Name: Buspirone Hydrochloride
  • Active Ingredient(s): 15 mg/1 BUSPIRONE
  • Administration Route(s): ORAL
  • Dosage Form(s): CAPSULE

Labeler Information

Field Name Field Value
Labeler Name: EPIC PHARMA, LLC
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA218628
Marketing Category: ANDA
Start Marketing Date:3/13/2025

Package Information

No. Package Code Package Description Billing Unit
142806-833-18180 CAPSULE in 1 BOTTLE (42806-833-18)
242806-833-6060 CAPSULE in 1 BOTTLE (42806-833-60)

NDC Record

Field Name Field Value Definition
PRODUCT NDC42806-833The 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 NAMEBuspirone 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 NAMEBuspirone HydrochlorideThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMECAPSULEThe 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 DATE3/13/2025Indicates 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.
MARKETING CATEGORY NAMEANDAThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
APPLICATION NUMBERANDA218628The translation of the dosage form Code submitted by the firm.
LABELER NAMEEPIC PHARMA, LLCThis is the date that the labeler indicates was the start of its marketing of the drug product.
SUBSTANCE NAMEBUSPIRONEAn 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 

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This page was last updated on: 12/19/2025

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