52709-1701 : Odactra Sublingual Tablet


NDC52709-1701
Labeler: Alk-abelló A/S
Product Type: Standardized Allergenic
Drug Name: Odactra
Dosage Form: Sublingual Tablet
Application #: BLA125592
Rev. Date: 


Appearance:


Shapes:  Round
Colors:  White
Size (mm): 12
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

  • 52709-1701-3: 3 BLISTER PACK IN 1 CARTON (52709‑1701‑3) > 10 TABLET IN 1 BLISTER PACK (52709‑1701‑1)
  • 52709-1701-5: 1 BLISTER PACK IN 1 CARTON (52709‑1701‑5) > 5 TABLET IN 1 BLISTER PACK

Active Ingredients:

  • Dermatophagoides Pteronyssinus
  • Dermatophagoides Farinae

Dosage Strength:

  • 6 [arb'U]/1
  • 6 [arb'U]/1

Inactive Ingredients:

  • Marine Non-gelling Gelatin, High Mw
  • Marine Non-gelling Gelatin
  • Mannitol
  • Sodium Hydroxide /

Pharmaceutical Classes:

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

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.