Isoxsuprine Hydrochloride Tablets, USP

Manufacturer: Bi-Coastal Pharmaceutical Corporation | ECI Pharmaceuticals, LLC
Effective date: 2012-06-06
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-02 01:47:07

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:

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

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

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 42582-100-10

Isoxsuprine HCl tablets, USP 20 mg
Bottles of 1000 NDC 42582-200-20

Isoxsuprine HCl tablets, USP 20 mg
Bottles of 100 NDC 42582-200-10

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 Pharmaceutical Corp.®
Red Bank, NJ 07701

Iss. 1/12

PRINCIPAL DISPLAY PANEL - 10 mg Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bi-Coastal
Pharmaceutical Corp.^®

NDC 42582-100-10

Isoxsuprine
Hydrochloride
Tablets, USP

10 mg

Rx only

100 Tablets

PRINCIPAL DISPLAY PANEL - 10 mg Bottle Label

PRINCIPAL DISPLAY PANEL - 20 mg Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bi-Coastal
Pharmaceutical Corp.^®

NDC 42582-200-10

Isoxsuprine
Hydrochloride
Tablets, USP

20 mg

Rx only

100 Tablets

PRINCIPAL DISPLAY PANEL - 20 mg Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42582-100-10	2021-11-17	C162847	48780-1	97449f38-b720-f6ea-e053-dbdaa90aa703	Isoxsuprine Hydrochloride Tablets, USP
42582-200-10	2021-11-17	C162847	48780-1	97449f38-b720-f6ea-e053-dbdaa90aa703	Isoxsuprine Hydrochloride Tablets, USP
42582-200-20	2021-11-17	C162847	48780-1	97449f38-b720-f6ea-e053-dbdaa90aa703	Isoxsuprine Hydrochloride Tablets, USP
42582-100-10	2019-11-13	C162847	48780-1	97449f38-b720-f6ea-e053-dbdaa90aa703	Isoxsuprine Hydrochloride Tablets, USP
42582-200-10	2019-11-13	C162847	48780-1	97449f38-b720-f6ea-e053-dbdaa90aa703	Isoxsuprine Hydrochloride Tablets, USP
42582-200-20	2019-11-13	C162847	48780-1	97449f38-b720-f6ea-e053-dbdaa90aa703	Isoxsuprine Hydrochloride Tablets, USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42582-100-10	EA - Each	42582-100	bc2ec651-2b1a-4a6f-9eec-48b11ef3b920	1	2012-07-24
42582-200-10	EA - Each	42582-200	83843715-f3e9-4595-9ea6-06b1e8c5e69d	1	2013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
isoxsuprine hydrochloride	ACTIVE INGREDIENT	V74TEQ36CO	3
Isoxsuprine	ACTIVE MOIETY	R15UI3245N	3
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	3
Lactose Monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	3
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	3
Starch, Corn	INACTIVE INGREDIENT	O8232NY3SJ	3

Products#

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

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

ISOXSUPRINE HYDROCHLORIDE
Isoxsuprine
Lactose Monohydrate
Magnesium Stearate
Cellulose, Microcrystalline
Starch, Corn

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
42582-100	42582-100-10
42582-200	42582-200-10, 42582-200-20

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
Name	UNII	Kind
isoxsuprine hydrochloride	V74TEQ36CO	ACTIB
Lactose Monohydrate	EWQ57Q8I5X	IACT
Magnesium Stearate	70097M6I30	IACT
Cellulose, Microcrystalline	OP1R32D61U	IACT
Starch, Corn	O8232NY3SJ	IACT
isoxsuprine hydrochloride	V74TEQ36CO	ACTIB
Lactose Monohydrate	EWQ57Q8I5X	IACT
Magnesium Stearate	70097M6I30	IACT
Cellulose, Microcrystalline	OP1R32D61U	IACT
Starch, Corn	O8232NY3SJ	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 127 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Lactose Monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	PELLET / ORAL		640 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	GRANULE / ORAL		629 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		615 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	INHALANT / ORAL	0.08 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, DELAYED RELEASE PARTICLES / ORAL		580 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	PASTILLE / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		53 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Lactose Monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	POWDER / RESPIRATORY (INHALATION)		25 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL		173 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	POWDER / RESPIRATORY (INHALATION)	0.13 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	CAPSULE / ORAL	256.4 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET / BUCCAL	17.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE, DELAYED RELEASE / ORAL	789.6 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING / ORAL		187 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	INSERT / VAGINAL		147 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE / ORAL		2169 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	SUSPENSION, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		47 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / BUCCAL		18 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	PELLET / ORAL		1140 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	TABLET / BUCCAL	16.6 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE, FOR SUSPENSION / ORAL		278 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL		992 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	CAPSULE, DELAYED RELEASE / ORAL		216 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / SUBLINGUAL	43.2 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
Lactose Monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, ORALLY DISINTEGRATING / ORAL		366 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
Lactose Monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION / INTRAMUSCULAR		150 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	TABLET, ORALLY DISINTEGRATING / ORAL		100 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	POWDER / ORAL		25 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Lactose Monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	CAPSULE, EXTENDED RELEASE / ORAL		5364 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET / SUBLINGUAL	17.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
Lactose Monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii candidate 38 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	PELLET / ORAL		24 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Lactose Monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET / ORAL		4384 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING / ORAL		1800 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Lactose Monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	CAPSULE, COATED PELLETS / ORAL		265 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
Lactose Monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET / BUCCAL		43 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, DELAYED RELEASE / ORAL		144 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	CAPSULE / ORAL		5785 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	INSERT / VAGINAL		69 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Lactose Monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INSERT / VAGINAL		2282 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	IMPLANT / INTRAVITREAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	CAPSULE, EXTENDED RELEASE / ORAL		194 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	SUSPENSION / ORAL		1600 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE / ORAL		29520 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FOR SUSPENSION / ORAL		131 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Lactose Monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, DELAYED RELEASE / ORAL		2313 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	SYSTEM / INTRAVITREAL	0.02 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
Lactose Monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	CAPSULE / ORAL		3990 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	POWDER, FOR SOLUTION / ORAL		690 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Lactose Monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS		214 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE / ORAL		127 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Lactose Monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY	47.5 mg		Exact identifier — unii candidate 38 equally ranked IID candidates
Lactose Monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	750 mg		Exact identifier — unii candidate 38 equally ranked IID candidates
Lactose Monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	POWDER / ORAL		50 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
Lactose Monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION / INTRAVENOUS	900 mg		Exact identifier — unii candidate 38 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
1351f07e-ce7b-43f8-b45b-da7dbb28cfd6			47134a96-77d0-4211-90b8-e2a857586d7b	2021-11-17	Adverse reactions	Exact identifier spl set id: 47134a96-77d0-4211-90b8-e2a857586d7b

Reported adverse events (FAERS/openFDA)#

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