NDC 59617-0016

Oralair 300 IR

Anthoxanthum Odoratum Pollen, Dactylis Glomerata Pollen, Lolium Perenne Pollen, Phleum Pratense Pollen, And Poa Pratensis Pollen

Oralair 300 IR is a Sublingual Tablet, Orally Disintegrating in the Standardized Allergenic category. It is labeled and distributed by Stallergenes. The primary component is Anthoxanthum Odoratum Pollen; Dactylis Glomerata Pollen; Lolium Perenne Pollen; Phleum Pratense Pollen; Poa Pratensis Pollen.

• Product ID: 59617-0016_08317321-144b-488d-8756-6f847731ae45
• NDC: 59617-0016
• Product Type: Standardized Allergenic
• Proprietary Name: Oralair 300 IR
• Generic Name: Anthoxanthum Odoratum Pollen, Dactylis Glomerata Pollen, Lolium Perenne Pollen, Phleum Pratense Pollen, And Poa Pratensis Pollen
• Dosage Form: Tablet, Orally Disintegrating
• Route of Administration: SUBLINGUAL
• Marketing Start Date: 2014-04-30
• Marketing Category: BLA / BLA
• Application Number: BLA125471
• Labeler Name: Stallergenes
• Substance Name: ANTHOXANTHUM ODORATUM POLLEN; DACTYLIS GLOMERATA POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN
• Active Ingredient Strength: 300 [IR]/1; [IR]/1; [IR]/1; [IR]/1; [IR]/1
• Pharm Classes: Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 59617-0016-1

1 BLISTER PACK in 1 BOX (59617-0016-1) > 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

• Marketing Start Date: 2014-04-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 59617-0016-1 [59617001601]

Oralair 300 IR TABLET, ORALLY DISINTEGRATING

• Marketing Category: BLA
• Application Number: BLA125471
• Product Type: STANDARDIZED ALLERGENIC
• Billing Unit: EA
• Marketing Start Date: 2014-04-30
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
ANTHOXANTHUM ODORATUM POLLEN	300 [IR]/1

Pharmacological Class

• Standardized Pollen Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Pollen [CS]
• Allergens [CS]
• Standardized Pollen Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Pollen [CS]
• Allergens [CS]
• Standardized Pollen Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Pollen [CS]
• Allergens [CS]
• Standardized Pollen Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Pollen [CS]
• Allergens [CS]

NDC Crossover Matching brand name "Oralair 300 IR" or generic name "Anthoxanthum Odoratum Pollen, Dactylis Glomerata Pollen, Lolium Perenne Pollen, Phleum Pratense Pollen, And Poa Pratensis Pollen"

NDC	Brand Name	Generic Name
59617-0010	Oralair	ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, and POA PRATENSIS POLLEN
59617-0015	Oralair	ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, and POA PRATENSIS POLLEN
59617-0016	Oralair	ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, and POA PRATENSIS POLLEN
59617-0020	Oralair	ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, and POA PRATENSIS POLLEN
59617-0025	Oralair	ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, and POA PRATENSIS POLLEN
82454-0015	Oralair	ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, and POA PRATENSIS POLLEN