Isoxsuprine Hydrochloride Tablets, USP

Manufacturer: Vedco dba Valdar
Effective date: 2012-01-02
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:14:04

Label at a glance#

ProductISOXSUPRINE HYDROCHLORIDE

Active ingredientisoxsuprine hydrochloride

Label structure11 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:

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

QUANTITATIVE INGREDIENT INFORMATION

SPL UNCLASSIFIED SECTION

Each tablet taken orally contains 20mg Isoxsuprine Hydrochloride.

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 has 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 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

DOSAGE & ADMINISTRATION SECTION

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

HOW SUPPLIED

HOW SUPPLIED SECTION

Isoxsuprine HCl tablets, USP 20 mg

Bottles of 1000 NDC 63549-919-53

COMPOSITION

INACTIVE INGREDIENT SECTION

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

SPL UNCLASSIFIED SECTION

Manufactured For:
Valdar
St. Joseph, MO 64507

PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 63549-919-53

Isoxsuprine
Hydrochloride
Tablets
USP
20 mg

1000 Tablets

Rx Only

VALDAR

PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1298799	isoxsuprine HCl 20 MG Oral Tablet	PSN	1
1298799	isoxsuprine hydrochloride 20 MG Oral Tablet	SCD	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63549-919-53	2019-11-13	C162847	48780-1	97449f38-d1ba-f6ea-e053-dbdaa90aa703	Isoxsuprine Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63549-919-53	ISOXSUPRINE HYDROCHLORIDE	1000 in 1 BOTTLE, PLASTIC	TABLET	1000		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63549-919	ISOXSUPRINE HYDROCHLORIDE TABLET [VEDCO DBA VALDAR]	1	Legacy NDC, 1 package rows	20120207_908691b4-7950-4f3e-bbea-ea568fee7ac3.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
isoxsuprine hydrochloride	ACTIVE INGREDIENT	V74TEQ36CO	1
Isoxsuprine	ACTIVE MOIETY	R15UI3245N	1
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	1
Lactose Monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	1
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	1
Starch, Corn	INACTIVE INGREDIENT	O8232NY3SJ	1

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
63549-919	63549-919-53

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 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

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
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE, FOR SUSPENSION / ORAL		278 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Lactose Monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INSERT / VAGINAL		2282 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
Lactose Monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, DELAYED RELEASE / ORAL		2313 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
Lactose Monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION / SUBCUTANEOUS		98 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	TABLET, COATED / ORAL		1301 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE, DELAYED RELEASE / ORAL		366 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	TABLET, EXTENDED RELEASE / ORAL		184 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	SUSPENSION, EXTENDED RELEASE / ORAL		113 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Lactose Monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	CAPSULE, COATED PELLETS / ORAL		265 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	CAPSULE / ORAL	256.4 mg		Exact identifier — unii candidate 39 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
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	POWDER / ORAL		25 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FOR SUSPENSION / ORAL		131 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	TABLET, DELAYED RELEASE / ORAL		713 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING / ORAL		187 mg	Exact identifier — unii candidate 39 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 / BUCCAL	17.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii candidate 22 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	LOZENGE / TRANSMUCOSAL		100 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	TABLET / BUCCAL	16.6 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
Lactose Monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	GRANULE, FOR SUSPENSION / ORAL	NA		Exact identifier — unii candidate 38 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	TABLET, FILM COATED / ORAL		2000 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Lactose Monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS	107 mg		Exact identifier — unii candidate 38 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL		992 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TROCHE / ORAL		315 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		9 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE, EXTENDED RELEASE / ORAL		1246 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	GRANULE / ORAL		629 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Lactose Monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		150 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	POWDER, FOR SUSPENSION / ORAL		34 mg	Exact identifier — unii candidate 22 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	CAPSULE, EXTENDED RELEASE / ORAL		194 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	TABLET / SUBLINGUAL		409 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Lactose Monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	690 mg		Exact identifier — unii candidate 38 equally ranked IID candidates
Lactose Monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	PELLET / ORAL		640 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
Lactose Monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	CAPSULE, DELAYED RELEASE / ORAL		2087 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IMPLANT / INTRAVITREAL	1.66 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	LOZENGE / ORAL		420 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	PASTILLE / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, DELAYED RELEASE / ORAL		2210 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	DROPS / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	POWDER, FOR SUSPENSION / ORAL		4441 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		21 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	POWDER / RESPIRATORY (INHALATION)	0.13 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
Lactose Monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, CHEWABLE / ORAL		1412 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
Lactose Monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, EXTENDED RELEASE / ORAL		2575 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	INSERT / VAGINAL		69 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	SUSPENSION / ORAL		900 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FOR SUSPENSION / ORAL		20100 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 39 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	SUSPENSION, EXTENDED RELEASE / ORAL		1120 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	CREAM / TOPICAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	CAPSULE, EXTENDED RELEASE / ORAL		117 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Lactose Monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS		174 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	POWDER / TOPICAL		104 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Lactose Monohydrate	LACTOSE MONOHYDRATE	EWQ57Q8I5X	GRANULE / ORAL		8946 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
e6f0f0dd-940a-490f-a404-56dd561264e6			908691b4-7950-4f3e-bbea-ea568fee7ac3	2012-01-02	Adverse reactions	Exact identifier spl id: e6f0f0dd-940a-490f-a404-56dd561264e6 spl set id: 908691b4-7950-4f3e-bbea-ea568fee7ac3

Reported adverse events (FAERS/openFDA)#

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