NDC 49884-113 Propafenone Hydrochloride

Capsule, Extended Release Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
49884-113
Proprietary Name:
Propafenone Hydrochloride
Non-Proprietary Name: [1]
Propafenone Hydrochloride
Substance Name: [2]
Propafenone Hydrochloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Capsule, Extended Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Par Pharmaceutical, Inc.
    Labeler Code:
    49884
    FDA Application Number: [6]
    ANDA078540
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    01-03-2011
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    ORANGE (C48331 - WHITE BODY)
    RED (C48326 - WHITE BODY)
    WHITE (C48325 - WHITE BODY)
    Shape:
    CAPSULE (C48336)
    Size(s):
    23 MM
    27 MM
    22 MM
    Imprint(s):
    PAR;210
    PAR;211
    PAR;209
    Score:
    1

    Product Packages

    NDC Code 49884-113-01

    Package Description: 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

    NDC Code 49884-113-02

    Package Description: 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

    Price per Unit: $0.70713 per EA

    NDC Code 49884-113-05

    Package Description: 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

    Price per Unit: $0.70713 per EA

    NDC Code 49884-113-09

    Package Description: 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

    Price per Unit: $0.70713 per EA

    NDC Code 49884-113-10

    Package Description: 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

    Product Details

    What is NDC 49884-113?

    The NDC code 49884-113 is assigned by the FDA to the product Propafenone Hydrochloride which is a human prescription drug product labeled by Par Pharmaceutical, Inc.. The product's dosage form is capsule, extended release and is administered via oral form. The product is distributed in 5 packages with assigned NDC codes 49884-113-01 100 capsule, extended release in 1 bottle, plastic , 49884-113-02 60 capsule, extended release in 1 bottle, plastic , 49884-113-05 500 capsule, extended release in 1 bottle, plastic , 49884-113-09 90 capsule, extended release in 1 bottle, plastic , 49884-113-10 1000 capsule, extended release in 1 bottle, plastic . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Propafenone Hydrochloride?

    Propafenone HCl Extended Release Capsules, USP are indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease.Usage Considerations: The use of propafenone ER capsules in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use propafenone ER capsules to control ventricular rate during AF. Some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. Concomitant treatment with drugs that increase the functional atrioventricular (AV) nodal refractory period is recommended. The effect of propafenone on mortality has not been determined [see BOXED WARNING].

    What are Propafenone 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.

    Which are Propafenone Hydrochloride UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Propafenone 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. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Propafenone Hydrochloride?

    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: 861156 - propafenone HCl 225 MG 12HR Extended Release Oral Capsule
    • RxCUI: 861156 - 12 HR propafenone hydrochloride 225 MG Extended Release Oral Capsule
    • RxCUI: 861156 - propafenone hydrochloride 225 MG 12 HR Extended Release Oral Capsule
    • RxCUI: 861164 - propafenone HCl 325 MG 12HR Extended Release Oral Capsule
    • RxCUI: 861164 - 12 HR propafenone hydrochloride 325 MG Extended Release Oral Capsule

    Which are the Pharmacologic Classes for Propafenone Hydrochloride?

    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

    Propafenone


    Propafenone is used to treat arrhythmia (irregular heartbeat) and to maintain a normal heart rate. Propafenone is in a class of medications called antiarrhythmics. It works by acting on the heart muscle to improve the heart's rhythm.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] 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.

    [2] What is the Substance Name? - 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.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] 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.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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] 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".