NDC 82454-0015

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 Cenexi Hsc. The primary component is Dactylis Glomerata Pollen; Anthoxanthum Odoratum Pollen; Lolium Perenne Pollen; Phleum Pratense Pollen; Poa Pratensis Pollen.

• Product ID: 82454-0015_d44ece12-6365-fef4-e053-2a95a90a0dec
• NDC: 82454-0015
• 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 /
• Application Number: BLA125471
• Labeler Name: CENEXI HSC
• Substance Name: DACTYLIS GLOMERATA POLLEN; ANTHOXANTHUM ODORATUM 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: 2022-12-31

Packaging

NDC 82454-0015-2

30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (82454-0015-2)

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

Drug Details

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