LORAZEPAM- lorazepam tablet 
DIRECTRX

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LORAZEPAM .5mg

DESCRIPTION

Lorazepam, an antianxiety agent, has the chemical formula, 7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one:
Lorazepam structure

It is a nearly white powder almost insoluble in water. Each Lorazepam Tablet, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam. The inactive ingredients present are Lactose Anhydrous, Microcrystalline Cellulose, Polacrilin Potassium and Magnesium Stearate.

CLINICAL PHARMACOLOGY

INDICATIONS AND USAGE

Lorazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.

The effectiveness of Lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.

CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

ADVERSE REACTIONS

OVERDOSAGE

DOSAGE AND ADMINISTRATION

HOW SUPPLIED

PRINCIPAL DISPLAY PANEL

143

LORAZEPAM 
lorazepam tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-143(NDC:64125-904)
Route of Administration ORAL DEA Schedule CIV    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LORAZEPAM (UNII: O26FZP769L) (LORAZEPAM - UNII:O26FZP769L) LORAZEPAM 0.5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
POLACRILIN POTASSIUM (UNII: 0BZ5A00FQU)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
Color white Score score with uneven pieces
Shape ROUND Size 5mm
Flavor Imprint Code EP;904
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:61919-143-60 60 in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2016
2 NDC:61919-143-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078203 06/01/2016
Labeler - DIRECTRX (079254320)
Establishment
Name Address ID/FEI Business Operations
DIRECT RX 079254320 repack(61919-143)

Revised: 6/2016
Document Id: 343d5211-54be-7414-e054-00144ff8d46c
Set id: 2c5ede2a-3388-04e7-e054-00144ff8d46c
Version: 2
Effective Time: 20160601
 
DIRECTRX