ALFUZOSIN HYDROCHLORIDE- alfuzosin hydrochloride tablet, extended release
DirectRX

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ALFUZOSIN HYDROCHLORIDE

Indications and Usage

Dosage and Administration

Dosage forms and Strengths

Contraindications

Warnings and Precautions

Adverse Reactions

Drug Interactions

Use in Specific Populations

Overdosage

Description

Clinical Pharmacology

Nonclinical Toxicology

Clinical Studies

How Supplied

Patient Counseling Information

Patient Information

SPL Unclassified

Package Label

Label

ALFUZOSIN HYDROCHLORIDE
alfuzosin hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-349(NDC:47335-956)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALFUZOSIN HYDROCHLORIDE (UNII: 75046A1XTN) (ALFUZOSIN - UNII:90347YTW5F) ALFUZOSIN HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSES (UNII: 3NXW29V3WO)
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TALC (UNII: 7SEV7J4R1U)
HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 956
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:61919-349-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 12/21/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079057 12/21/2015
Labeler - DirectRX (079254320)
Establishment
Name Address ID/FEI Business Operations
DirectRX 079254320 repack(61919-349)

Revised: 12/2015
Document Id: 27f6bec9-90aa-4c4c-e054-00144ff8d46c
Set id: 27f6bec9-90a9-4c4c-e054-00144ff8d46c
Version: 1
Effective Time: 20151228
DirectRX