0025-2924 NDC - CALAN SR (VERAPAMIL HYDROCHLORIDE)

Drug Information

Product NDC: 0025-2924

Proprietary Name: CALAN SR

Non Proprietary Name: verapamil hydrochloride

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


Administration Route(s): ORAL

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

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: Pfizer Laboratories Div Pfizer Inc
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA019152
Marketing Category: NDA
Start Marketing Date:6/1/2021

Package Information

No. Package Code Package Description Billing Unit
10025-2924-31100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0025-2924-31)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0025-2924The 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 NAMECALAN SRThe 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 DATE6/1/2021This is the date that the labeler indicates was the start of its marketing of the drug product.
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 NUMBERNDA019152This 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 NAMEPfizer Laboratories Div Pfizer IncName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEVERAPAMIL HYDROCHLORIDEThe following is the list of active ingredients in this product. 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 STRENGTH240 
ACTIVE INGRED UNITmg/1 
PHARM CLASSESCalcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA] 

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This page was last updated on: 9/15/2022