50090-5797 NDC - BUSPIRONE HYDROCHLORIDE

Drug Information

Product NDC: 50090-5797
Proprietary Name: Buspirone Hydrochloride
Non Proprietary Name: Buspirone Hydrochloride
Active Ingredient(s): 5 mg/1 BUSPIRONE HYDROCHLORIDE
Administration Route(s): ORAL
Dosage Form(s): TABLET

Labeler Information

Field Name	Field Value
Labeler Name:	A-S Medication Solutions
Product Type:	HUMAN PRESCRIPTION DRUG
FDA Application Number:	ANDA210907
Marketing Category:	ANDA
Start Marketing Date:	11/14/2019

Package Information

No.	Package Code	Package Description	Billing Unit
1	50090-5797-1	60 TABLET in 1 BOTTLE (50090-5797-1)	EA
2	50090-5797-2	90 TABLET in 1 BOTTLE (50090-5797-2)	EA

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	50090-5797	The 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 NAME	HUMAN PRESCRIPTION DRUG	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME	Buspirone Hydrochloride	A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
NON PROPRIETARY NAME	Buspirone Hydrochloride	This is the date that the labeler indicates was the start of its marketing of the drug product.
DOSAGE FORM NAME	TABLET	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	ORAL	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	11/14/2019	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	ANDA	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
APPLICATION NUMBER	ANDA210907	The translation of the dosage form Code submitted by the firm.
LABELER NAME	A-S Medication Solutions	This is the date that the labeler indicates was the start of its marketing of the drug product.
SUBSTANCE NAME	BUSPIRONE HYDROCHLORIDE	An 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 STRENGTH	5
ACTIVE INGRED UNIT	mg/1

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This page was last updated on: 11/21/2025

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