NDC 0591-2880 Verapamil Hydrochloride
Capsule, Delayed Release Pellets Oral

Product Information

Verapamil Hydrochloride is a human prescription drug product labeled by Teva Pharmaceuticals Inc. The product's dosage form is capsule, delayed release pellets and is administered via oral form.

Product Code0591-2880
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Verapamil Hydrochloride
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Verapamil Hydrochloride
Product Type What kind of product is this?
Indicates 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.
Human Prescription Drug
Dosage FormCapsule, Delayed Release Pellets - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; the drug itself is in the form of granules to which enteric coating has been applied, thus delaying release of the drug until its passage into the intestines.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Teva Pharmaceuticals Inc
Labeler Code0591
FDA Application Number What is the FDA Application Number?
This 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.
NDA019614
Marketing Category What is the Marketing Category?
Product 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.
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
05-29-1990
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2023
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Verapamil Hydrochloride?


Product Characteristics

Color(s)YELLOW (C48330)
ShapeCAPSULE (C48336)
Size(s)18 MM
Imprint(s)60274;120;MG
Score1

Product Packages

NDC 0591-2880-01

Package Description: 100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC

Price per Unit: $1.10876 per EA

Product Details

What are Verapamil Hydrochloride Active Ingredients?

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.

Verapamil Hydrochloride Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 897624 - verapamil HCl 240 MG 24HR Extended Release Oral Capsule
  • RxCUI: 897624 - 24 HR verapamil hydrochloride 240 MG Extended Release Oral Capsule
  • RxCUI: 897624 - verapamil hydrochloride 240 MG 24HR Extended Release Oral Capsule

Verapamil Hydrochloride Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Patient Education

Verapamil

Verapamil is pronounced as (ver ap' a mil)

Why is verapamil medication prescribed?
Verapamil is used to treat high blood pressure and to control angina (chest pain). The immediate-release tablets are also used alone or with other medications to prevent ...
[Read More]

* Please review the disclaimer below.

Verapamil Hydrochloride Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Ivabradine



Concurrent use of verapamil increases exposure to ivabradine and may exacerbate bradycardia and conductions disturbances. Avoid concomitant use of ivabradine and verapamil.


Mammalian Target Of Rapamycin (Mtor) Inhibitors



In a study of 25 healthy volunteers with co-administration of verapamil with sirolimus, whole blood sirolimus Cmax and AUC were increased 130% and 120%, respectively. Plasma S (-) verapamil Cmax and AUC were both increased 50%. Co-administration of verapamil with everolimus in 16 healthy volunteers increased the Cmax and AUC of everolimus by 130% and 250%, respectively. With concomitant use of mTOR inhibitors (e.g., sirolimus, temsirolimus, and everolimus) and verapamil, consider appropriate dose reductions of both medications.


Principal Display Panel - 120 Mg Capsule Bottle Label



NDC 0591-2880-01

120
mg

Verapamil
Hydrochloride
Sustained-Release
Capsules

Actavis

100 Capsules
Rx Only


Principal Display Panel - 180 Mg Capsule Bottle Label



NDC 0591-2882-01

180
mg

Verapamil
Hydrochloride
Sustained-Release
Capsules

Actavis

100 Capsules
Rx Only


Principal Display Panel - 240 Mg Capsule Bottle Label



NDC 0591-2884-01

240
mg

Verapamil
Hydrochloride
Sustained-Release
Capsules

Actavis

100 Capsules
Rx Only


Principal Display Panel - 360 Mg Capsule Bottle Label



NDC 0591-2886-01

360
mg

Verapamil
Hydrochloride
Sustained-Release
Capsules

Actavis

100 Capsules
Rx Only


* Please review the disclaimer below.