NDC 52709-1701

Odactra

Dermatophagoides Pteronyssinus And Dermatophagoides Farinae

Odactra is a Sublingual Tablet in the Standardized Allergenic category. It is labeled and distributed by Alk-abello A S. The primary component is Dermatophagoides Pteronyssinus; Dermatophagoides Farinae.

• Product ID: 52709-1701_0b7229a0-4606-42a6-aabb-0de8f5a9c0dd
• NDC: 52709-1701
• Product Type: Standardized Allergenic
• Proprietary Name: Odactra
• Generic Name: Dermatophagoides Pteronyssinus And Dermatophagoides Farinae
• Dosage Form: Tablet
• Route of Administration: SUBLINGUAL
• Marketing Start Date: 2018-01-01
• Marketing Category: BLA / BLA
• Application Number: BLA125592
• Labeler Name: ALK-Abello A S
• Substance Name: DERMATOPHAGOIDES PTERONYSSINUS; DERMATOPHAGOIDES FARINAE
• Active Ingredient Strength: 6 [arb'U]/1; [arb'U]/1
• Pharm Classes: Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS],Insect Proteins [CS],Allergens [CS],Allergens [CS],Insect Proteins [CS],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 52709-1701-3

3 BLISTER PACK in 1 CARTON (52709-1701-3) > 10 TABLET in 1 BLISTER PACK (52709-1701-1)

• Marketing Start Date: 2018-01-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52709-1701-1 [52709170101]

Odactra TABLET

• Marketing Category: BLA
• Application Number: BLA125592
• Product Type: STANDARDIZED ALLERGENIC
• Billing Unit: EA
• Marketing Start Date: 2018-01-01

NDC 52709-1701-3 [52709170103]

Odactra TABLET

• Marketing Category: BLA
• Application Number: BLA125592
• Product Type: STANDARDIZED ALLERGENIC
• Billing Unit: EA
• Marketing Start Date: 2018-01-01

NDC 52709-1701-5 [52709170105]

Odactra TABLET

• Marketing Category: BLA
• Application Number: BLA125592
• Product Type: STANDARDIZED ALLERGENIC
• Marketing Start Date: 2018-01-01

Drug Details

Active Ingredients

Ingredient	Strength
DERMATOPHAGOIDES PTERONYSSINUS	6 [arb'U]/1

Pharmacological Class

• Standardized Insect Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Antigens
• Dermatophagoides [CS]
• Insect Proteins [CS]
• Allergens [CS]
• Allergens [CS]
• Insect Proteins [CS]
• Standardized Insect Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Antigens
• Dermatophagoides [CS]