Drug Information

Product NDC: 59762-0132

Proprietary Name: Trandolapril and Verapamil Hydrochloride

Non Proprietary Name: Trandolapril and Verapamil Hydrochloride

Active Ingredient(s):
  • 2 mg/1 TRANDOLAPRIL;

Administration Route(s): ORAL


Pharmacy Class(es):
  • Angiotensin Converting Enzyme Inhibitor [EPC];
  • Angiotensin-converting Enzyme Inhibitors [MoA];
  • 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: Greenstone LLC
FDA Application Number: NDA020591
Marketing Category: NDA
Start Marketing Date:2/25/2015
End Marketing Date:5/28/2021

Package Information

No. Package Code Package Description Billing Unit
159762-0132-1100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59762-0132-1)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC59762-0132The 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 NAMETrandolapril and Verapamil HydrochlorideThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME SUFFIXERA 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 NAMETrandolapril and Verapamil 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 DATE2/25/2015This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE5/28/2021This 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.
MARKETING CATEGORY NAMENDAProduct 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 NUMBERNDA020591This 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 NAMEGreenstone LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMETRANDOLAPRIL; VERAPAMIL HYDROCHLORIDEThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
PHARM CLASSESAngiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],P-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: 7/22/2020