ORALAIR Tablets Ref.[27771] Active ingredients: Grass pollen

Source: FDA, National Drug Code (US)  Revision Year: 2021 

Product description

ORALAIR (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) is a mixed allergen extract of the following five pollens: Sweet Vernal (Anthoxanthum odoratum L), Orchard (Dactylis glomerata L), Perennial Rye (Lolium perenne L), Timothy (Phleum pratense L), and Kentucky Blue Grass (Poa pratensis L).

ORALAIR is available as a sublingual tablet in the following strengths:

  • 100 IR (equivalent to approximately 3000 BAU (bioequivalent allergy units)
  • 300 IR (equivalent to approximately 9000 BAU

Inactive ingredients: mannitol, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate and lactose monohydrate.

Dosage Forms and Strengths

ORALAIR tablets are available as follows:

  • ORALAIR 100 IR tablets are round and biconvex, slightly speckled white to beige with “100” engraved on both sides
  • ORALAIR 300 IR tablets are round and biconvex, slightly speckled white to beige with “300” engraved on both sides
How Supplied

ORALAIR is available as a sublingual tablet equivalent to 100 IR and 300 IR of five grass mixed pollens allergen extract.

 DescriptionNDC Number
Children and Adolescents
Sample Kit
(5 to 17 years of age) 		One box of the 100 IRStarter Pack
Two boxes of the 300 IR Sample Packs 		NDC 59617-0020-1
Adult
Sample Kit
(18 to 65 years of age) 		One box of 300 IR StarterPack
Two boxes of 300 IR Sample Packs 		NDC 59617-0025-1
Children and Adolescents
Starter Pack
(5 to 17 years of age) 		1 blister pack of three 100IR tablets NDC 59617-0010-1
Adult
Starter Pack
(18 to 65 years of age) 		1 blister pack of three 300IR tablets NDC 59617-0016-1
Sample Pack 1 blister pack of three 300IR tablets NDC 59617-0015-3
Commercial Pack 1 blister pack of thirty 300IR tablets NDC 59617-0015-2

Manufactured by: Stallergenes SAS, Antony, 92183, France

U.S. License #1893

Distributed by: GREER Laboratories, Inc., Lenoir, N.C. 28645

Drugs

Drug Countries
ORALAIR Austria, Canada, Estonia, Spain, France, Croatia, Ireland, Lithuania, Netherlands, New Zealand, Poland, Romania, Tunisia
 
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