0615-3588 NDC - VERAPAMIL HYDROCHLORIDE

Drug Information

Product NDC: 0615-3588

Proprietary Name: Verapamil Hydrochloride

Non Proprietary Name: Verapamil Hydrochloride

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


Administration Route(s): ORAL

Dosage Form(s): TABLET, FILM COATED, EXTENDED RELEASE

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

Labeler Information

Labeler Name: NCS HealthCare of KY, Inc dba Vangard Labs
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA074330
Marketing Category: ANDA
Start Marketing Date:2/23/2012

Package Information

No. Package Code Package Description Billing Unit
10615-3588-3930 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0615-3588-39)

NDC Record

Field Name Field Value Definition
PRODUCT NDC0615-3588The 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 NAMEVerapamil 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 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 COATED, EXTENDED RELEASEThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE2/23/2012This 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.
APPLICATION NUMBERANDA074330This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMENCS HealthCare of KY, Inc dba Vangard LabsName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEVERAPAMIL HYDROCHLORIDEThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH180 
ACTIVE INGRED UNITmg/1 
PHARM CLASSESP-Glycoprotein Inhibitors [MoA],Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA] 

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This page was last updated on: 5/17/2019