FDA Product

Isradipine

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Isradipine

FDA Product Code

68151-1333

Regulatory Information

NDC Product Code

68151-1333

Application Number

ANDA077317

Marketing Category

C73584

Effective Date

March 12, 2012

Territorial Authority

USA

FDA Title

Isradipine Capsules, USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

3

Company Information

ManufacturerCarilion Materials Management

DUNS Number

079239644

Active Ingredients

Quantity: 5 mg in 1 1

Code: YO1UK1S598

Class Code: ACTIB

Inactive Ingredients

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

ANHYDROUS LACTOSE

Code: 3SY5LH9PMK

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

POTASSIUM HYDROXIDE

Code: WZH3C48M4T

Class Code: IACT

GELATIN

Code: 2G86QN327L

Class Code: IACT

Active Moieties

ISRADIPINE

Code: YO1UK1S598

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