NDC 51293-605 Isoxsuprine Hydrochloride

Isoxsuprine Hydrochloride

NDC Product Code 51293-605

NDC CODE: 51293-605

Proprietary Name: Isoxsuprine Hydrochloride 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.

Non-Proprietary Name: Isoxsuprine Hydrochloride 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.

Product Characteristics

Color(s):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
8 MM
Imprint(s):
I10
20
Score: 2

NDC Code Structure

NDC 51293-605-01

Package Description: 100 TABLET in 1 BOTTLE

NDC 51293-605-10

Package Description: 1000 TABLET in 1 BOTTLE, PLASTIC

NDC Product Information

Isoxsuprine Hydrochloride with NDC 51293-605 is a a human prescription drug product labeled by Eci Pharmaceuticals Llc. The generic name of Isoxsuprine Hydrochloride is isoxsuprine hydrochloride. The product's dosage form is tablet and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1298799 and 1298834.

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Prescription Drug 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.

Isoxsuprine Hydrochloride Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • STARCH, CORN (UNII: O8232NY3SJ)

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.

Labeler Name: Eci Pharmaceuticals Llc
Labeler Code: 51293
Marketing Category: UNAPPROVED DRUG OTHER - 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.

Start Marketing Date: 08-23-2011 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 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.

Exclude Flag: N - NO 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".

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Information for Patients

Isoxsuprine Oral

Isoxsuprine Oral is pronounced as (eye sox' syoo preen)

Why is isoxsuprine oral medication prescribed?
Isoxsuprine is used to relieve the symptoms of central and peripheral vascular diseases such as arteriosclerosis, Buerger's disease, and Raynaud's disease....
[Read More]

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Isoxsuprine Hydrochloride Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Rx Only

Manufactured By:ECI Pharmaceuticals, LLCFort Lauderdale, FL 33309Iss. 04/12

Description

Each tablet taken orally contains Isoxsuprine Hydrochloride, USP with the following chemical structure:C18H23NO3 ∙ HClp-Hydroxy-α[1-[(methyl-2-phenoxy-ethyl)amino]ethyl]benzyl alcohol hydrochloride.Quantitative Ingredient Information: Each tablet taken orally contains 10 or 20 mg Isoxsuprine HClPharmacological Class: Peripheral Vasodilator

Indications

Based on a review of this drug by the National Academy of Sciences-National Research and/or other information, the FDA has classified the indications as follows:

Possibly Effective

  • For the relief of symptoms associated with cerebrovascular insufficiency.In peripheral vascular disease of arteriosclerosis obliterans, thromboangitis obliterans (Buerger's disease) and Raynaud's disease. Final classification of the less-than-effective indications requires further investigation.

Contraindications

There are no known contraindications to oral use when administered in recommended doses.Isoxsuprine Hydrochloride, USP should not be given immediately postpartum or in the presence of arterial bleeding.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Adverse Reactions

On rare occasion oral administration of the drug has been associated in time with the occurrence of hypotension, tachycardia, chest pain, nausea, vomiting, dizziness, abdominal distress, and severe rash. If rash appears, the drug should be discontinued.Although available evidence suggests a temporal association of these reactions with Isoxsuprine Hydrochloride, a causal relationship can be neither confirmed nor refuted.Beta Adrenergic receptor stimulants such as Isoxsuprine Hydrochloride have been used to inhibit pre-term labor.Maternal and fetal tachycardia may occur under such use. Hypocalcemia, hypoglycemia, hypotension and ileus have been reported to occur in infants whose mothers received Isoxsuprine Hydrochloride. Pulmonary edema has been reported in mothers treated with beta stimulants. Isoxsuprine Hydrochloride is neither approved nor recommended for use in the treatment of premature labor.

Dosage And Administration

Oral: 10 to 20 mg, three or four times daily.

How Supplied

Isoxsuprine HCl Tablets, USP 10 mg are white, round, biconvex tablets identified as "I10" debossed on one side and bisected on the other.Bottle of 100NDC 51293-606-01Bottle of 1000NDC 51293-606-10Isoxsuprine HCl Tablets, USP 20 mg are white, round, biconvex tablets identified as "20" debossed on one side and bisected on the other.Bottle of 100NDC 51293-605-01Bottle of 1000NDC 51293-605-10

Composition

Isoxsuprine HCl Tablets, 10 mg and 20 mg. These tablets contain the following Inactive Ingredients: Corn Starch, Lactose Monohydrate, Magnesium Stearate (Vegetable), Microcrystalline Cellulose.

* Please review the disclaimer below.