NDC 49288-0823

Treatment Set TS342922

Treatment Set Ts342922

Treatment Set TS342922 is a Intradermal; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Antigen Laboratories, Inc.. The primary component is Dermatophagoides Pteronyssinus; Dermatophagoides Farinae; Cynodon Dactylon Pollen; Ambrosia Artemisiifolia Pollen; Acer Negundo Pollen; Felis Catus Hair; Poa Pratensis Pollen; Ulmus Americana Pollen; Ambrosia Trifida Pollen; Ambrosia Psilostachya Pollen; Gallus Gallus Feather; Anser Anser Feather; Anas Platyrhynchos Feather; Plantago Lanceolata Pollen; Candida Albicans; Juniperus Virginiana Pollen; Cladosporium Cladosporioides; Penicillium Chrysogenum Var. Chrysogenum; Phoma Destructiva; Aureobasidium Pullulans Var. Pullutans; Rhizopus Stolonifer; Populus Deltoides Pollen; Betula Nigra Pollen; Fraxinus Americana Pollen; Quercus Alba Pollen; Pleospora Herbarum; Ustilago Nuda Hordei; Ustilago Maydis; Ustilago Avenae; Ustilago Tritici.

• Product ID: 49288-0823_da61c6b6-9055-4d5e-909c-eeb1bf0e016c
• NDC: 49288-0823
• Product Type: Human Prescription Drug
• Proprietary Name: Treatment Set TS342922
• Generic Name: Treatment Set Ts342922
• Dosage Form: Injection, Solution
• Route of Administration: INTRADERMAL; SUBCUTANEOUS
• Marketing Start Date: 1986-10-31
• Marketing Category: BLA / BLA
• Application Number: BLA102223
• Labeler Name: Antigen Laboratories, Inc.
• Substance Name: DERMATOPHAGOIDES PTERONYSSINUS; DERMATOPHAGOIDES FARINAE; CYNODON DACTYLON POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ACER NEGUNDO POLLEN; FELIS CATUS HAIR; POA PRATENSIS POLLEN; ULMUS AMERICANA POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; GALLUS GALLUS FEATHER; ANSER ANSER FEATHER; ANAS PLATYRHYNCHOS FEATHER; PLANTAGO LANCEOLATA POLLEN; CANDIDA ALBICANS; JUNIPERUS VIRGINIANA POLLEN; CLADOSPORIUM CLADOSPORIOIDES; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PHOMA DESTRUCTIVA; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER; POPULUS DELTOIDES POLLEN; BETULA NIGRA POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN; PLEOSPORA HERBARUM; USTILAGO NUDA HORDEI; USTILAGO MAYDIS; USTILAGO AVENAE; USTILAGO TRITICI
• Active Ingredient Strength: 16 [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL
• 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],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Dander [CS],Allergens [CS],Salivary Proteins and Peptides [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Feathers [CS],Allergens [CS],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [CS],Allergens [CS],Increased IgG Production [PE],Non-Standardized Feather Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Feathers [CS],Allergens [CS],Increased IgG Production [PE],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 49288-0823-3

10 mL in 1 VIAL, MULTI-DOSE (49288-0823-3)

• Marketing Start Date: 1986-10-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49288-0823-3 [49288082303]

Treatment Set TS342922 INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102223
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1986-10-31
• Inactivation Date: 2019-11-13

Drug Details

Active Ingredients

Ingredient	Strength
DERMATOPHAGOIDES PTERONYSSINUS	16 [AU]/mL

OpenFDA Data

• SPL SET ID: da65c4cc-0646-43f4-947d-27db80b5a34e
• Manufacturer:
  • Antigen Laboratories, Inc.
• UNII:
  • D1A2NG69CK
  • 9Y53ZS6I82
  • 3Y1PE1GCIG
  • 4K7Z7K7SWG
  • 1564HD0N96
  • A17SE577FM
  • 93963RFO1P
  • BV82OL2IZ8
  • 89BAT511BD
  • G684LX721Q
  • DO87T1U2CI
  • P6K070AR8V
  • PY0JA16R2G
  • PR9U2YPF3Q
  • Z4Y9ZSV4KK
  • K20Y81ACO3
  • RX18M46K8L
  • 175F461W10
  • 1FCM16V0FV
  • FEE198DK4Q
  • 0N3Z1P4B2W
  • 4D7G21HDBC
  • 57L1Z5378K
  • SCB8J7LS3T
  • 4ZWY20GTGO
  • 83B65P4796
  • KU1V1898XX
  • YIH315U1TU
  • 15XI414745
  • 476DVV63WP
• Pharm Class PE:
  • Cell-mediated Immunity [PE]
  • Increased IgG Production [PE]
  • Increased Histamine Release [PE]
• PHarm Class EPC:
  • Non-Standardized Fungal Allergenic Extract [EPC]
• NUI Code:
  • N0000185001
  • N0000175629
  • N0000171131
  • N0000185372
  • N0000169106
  • N0000184306

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]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Pollen [CS]
• Allergens [CS]
• Standardized Pollen Allergenic Extract [EPC]
• Standardized Pollen Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Pollen [CS]
• Allergens [CS]
• Non-Standardized Pollen Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Pollen [CS]
• Allergens [CS]
• Standardized Animal Hair Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Dander [CS]
• Allergens [CS]
• Salivary Proteins and Peptides [CS]
• Standardized Pollen Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Pollen [CS]
• Allergens [CS]
• Non-Standardized Pollen Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Pollen [CS]
• Allergens [CS]
• Non-Standardized Pollen Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Pollen [CS]
• Allergens [CS]
• Non-Standardized Pollen Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Pollen [CS]
• Allergens [CS]
• Non-Standardized Feather Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Feathers [CS]
• Allergens [CS]
• Non-Standardized Feather Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Feathers [CS]
• Allergens [CS]
• Increased IgG Production [PE]
• Non-Standardized Feather Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Feathers [CS]
• Allergens [CS]
• Increased IgG Production [PE]
• Non-Standardized Pollen Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Pollen [CS]
• Allergens [CS]
• Non-Standardized Fungal Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Fungal Proteins [CS]
• Allergens [CS]
• Non-Standardized Pollen Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Pollen [CS]
• Allergens [CS]
• Non-Standardized Fungal Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Fungal Proteins [CS]
• Allergens [CS]
• Non-Standardized Fungal Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Fungal Proteins [CS]
• Allergens [CS]
• Non-Standardized Fungal Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Fungal Proteins [CS]
• Allergens [CS]
• Non-Standardized Fungal Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Fungal Proteins [CS]
• Allergens [CS]
• Non-Standardized Fungal Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Fungal Proteins [CS]
• Allergens [CS]
• Non-Standardized Pollen Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Pollen [CS]
• Allergens [CS]
• Non-Standardized Pollen Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Pollen [CS]
• Allergens [CS]
• Non-Standardized Pollen Allergenic Extract [EPC]