FDA.reportPublic FDA data

Isoxsuprine Hydrochloride Tablets, USP

Manufacturer
BI-COASTAL PHARMA INTERNATIONAL LIMITED LIABILITY COMPANY
Effective date
2020-03-03
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:39:51

Label at a glance#

ProductISOXSUPRINE HYDROCHLORIDE
Active ingredientisoxsuprine hydrochloride
Label structure10 sections

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Rx Only

DESCRIPTION

DESCRIPTION SECTION

Each tablet taken orally contains Isoxsuprine Hydrochloride, USP with the following chemical structure:

Chemical Structure
Chemical Structure

C18H23NO3 • HCl

p-Hydroxy-α[1-[(methyl-2-phenoxy-ethyl)amino]ethyl]benzyl alcohol hydrochloride.

Quantitative Ingredient Information

SPL UNCLASSIFIED SECTION

Each tablet taken orally contains 10 or 20 mg Isoxsuprine HCl

Pharmacological Class

SPL UNCLASSIFIED SECTION

Peripheral Vasodilator

INDICATIONS

INDICATIONS & USAGE SECTION

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

SPL UNCLASSIFIED SECTION

  1. For the relief of symptoms associated with cerebrovascular insufficiency.
  2. 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

CONTRAINDICATIONS SECTION

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.

PRECAUTIONS

PRECAUTIONS SECTION

Pediatric Use

PEDIATRIC USE SECTION

Safety and effectiveness in pediatric patients have not been established.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

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 Hydrocholoride 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

DOSAGE & ADMINISTRATION SECTION

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

HOW SUPPLIED

HOW SUPPLIED SECTION

Isoxsuprine HCl tablets, USP 10 mg
Bottles of 100 NDC 42582-101-10

Isoxsuprine HCl tablets, USP 20 mg
Bottles of 1000 NDC 42582-201-20

Isoxsuprine HCl tablets, USP 20 mg
Bottles of 100 NDC 42582-201-10

COMPOSITION

SPL UNCLASSIFIED SECTION

Isoxsuprine HCl 10mg and 20mg tablets: These tablets contain the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate (vegetable), microcrystalline cellulose.

SPL UNCLASSIFIED SECTION

Distributed By:
Bi-Coastal Pharma International LLC
Red Bank, NJ 07701

Iss. 11/14

PRINCIPAL DISPLAY PANEL - 10 mg Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bi-Coastal Pharma International LLC

NDC 42582-101-10

Isoxsuprine
Hydrochloride
Tablets, USP

10 mg

Rx only

100 Tablets

PRINCIPAL DISPLAY PANEL - 10 mg Bottle LabelPRINCIPAL DISPLAY PANEL - 10 mg Bottle Label

PRINCIPAL DISPLAY PANEL - 20 mg Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bi-Coastal Pharma International LLC

NDC 42582-201-10

Isoxsuprine
Hydrochloride
Tablets, USP

20 mg

Rx only

100 Tablets

PRINCIPAL DISPLAY PANEL - 20 mg Bottle LabelPRINCIPAL DISPLAY PANEL - 20 mg Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42582-101-102020-03-03C16284748780-19d75b9d0-4ccc-f424-e053-dadaa90a57ceIsoxsuprine Hydrochloride Tablets, USP
42582-201-102020-03-03C16284748780-19d75b9d0-4ccc-f424-e053-dadaa90a57ceIsoxsuprine Hydrochloride Tablets, USP
42582-201-202020-03-03C16284748780-19d75b9d0-4ccc-f424-e053-dadaa90a57ceIsoxsuprine Hydrochloride Tablets, USP
42582-101-102020-01-31C16284748780-19d75b9d0-4ccc-f424-e053-dadaa90a57ceIsoxsuprine Hydrochloride Tablets, USP
42582-201-102020-01-31C16284748780-19d75b9d0-4ccc-f424-e053-dadaa90a57ceIsoxsuprine Hydrochloride Tablets, USP
42582-201-202020-01-31C16284748780-19d75b9d0-4ccc-f424-e053-dadaa90a57ceIsoxsuprine Hydrochloride Tablets, USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42582-101-10EA - Each42582-101ff04595c-02d8-4cce-8df9-a0c6dc99d6ce12016-09-02
42582-201-10EA - Each42582-2015ddd4884-4529-4582-966d-2fc40156f5d612016-09-02
42582-201-20EA - Each42582-201ed3bf256-d5cf-40a8-9e89-b262b64f11f312022-06-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42582-10142582-101-10
42582-20142582-201-10, 42582-201-20

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
isoxsuprine hydrochlorideV74TEQ36COACTIB
Lactose MonohydrateEWQ57Q8I5XIACT
Magnesium Stearate70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
Starch, CornO8232NY3SJIACT
isoxsuprine hydrochlorideV74TEQ36COACTIB
Lactose MonohydrateEWQ57Q8I5XIACT
Magnesium Stearate70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
Starch, CornO8232NY3SJIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
90ed1d50-b7e3-468e-8738-22ccab29d7d818d6b14d-3ceb-4922-8d54-8c5b0fe23d7c2021-10-05Adverse reactionsExact identifier
spl set id: 18d6b14d-3ceb-4922-8d54-8c5b0fe23d7c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.