0591-0343 NDC - VERAPAMIL HYDROCHLORIDE

Drug Information

Product NDC: 0591-0343

Proprietary Name:

Non Proprietary Name: Verapamil Hydrochloride

Active Ingredient(s):
  • 80 mg/1 VERAPAMIL HYDROCHLORIDE


Administration Route(s):

Dosage Form(s): TABLET, FILM COATED

Pharmacy Class(es):
  • Calcium Channel Antagonists [MoA];
  • Calcium Channel Blocker [EPC];
  • Cytochrome P450 3A Inhibitors [MoA];
  • Cytochrome P450 3A4 Inhibitors [MoA];
  • P-Glycoprotein Inhibitors [MoA]

Labeler Information

Labeler Name: Actavis Pharma, Inc.
Product Type: DRUG FOR FURTHER PROCESSING
FDA Application Number:
Marketing Category: DRUG FOR FURTHER PROCESSING
Start Marketing Date:10/1/1986

Package Information

No. Package Code Package Description Billing Unit
10591-0343-0044000 TABLET, FILM COATED in 1 BAG (0591-0343-00)
20591-0343-01100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0343-01)EA
30591-0343-05500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0343-05)EA
40591-0343-101000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0343-10)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0591-0343The 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.
NON PROPRIETARY NAMEVerapamil HydrochlorideThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLET, FILM COATEDThe translation of the dosage form Code submitted by the firm.
START MARKETING DATE10/1/1986This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct 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 NAMEActavis Pharma, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEVERAPAMIL HYDROCHLORIDEAn 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 STRENGTH80 
ACTIVE INGRED UNITmg/1 
PRODUCT NDC0591-0343The 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 NAMEDRUG FOR FURTHER PROCESSINGIndicates 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 NAMEVerapamil HydrochlorideThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLET, FILM COATEDThe translation of the dosage form Code submitted by the firm.
START MARKETING DATE10/1/1986This is the date that the labeler indicates was the start of its marketing of the drug product.
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 NAMEActavis Pharma, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEVERAPAMIL HYDROCHLORIDEAn 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 STRENGTH80 
ACTIVE INGRED UNITmg/1 

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This page was last updated on: 4/12/2024