NDC 49288-0811

Treatment Set TS340796

Treatment Set Ts340796

Treatment Set TS340796 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 Farinae; Dermatophagoides Pteronyssinus; Periplaneta Americana; Juglans Nigra Pollen; Cynodon Dactylon Pollen; Phleum Pratense Pollen; Amaranthus Retroflexus Pollen; Carya Illinoinensis Pollen; Carya Tomentosa Pollen.

• Product ID: 49288-0811_2413d900-60a6-4cfd-99b2-0ceccd0d1249
• NDC: 49288-0811
• Product Type: Human Prescription Drug
• Proprietary Name: Treatment Set TS340796
• Generic Name: Treatment Set Ts340796
• 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 FARINAE; DERMATOPHAGOIDES PTERONYSSINUS; PERIPLANETA AMERICANA; JUGLANS NIGRA POLLEN; CYNODON DACTYLON POLLEN; PHLEUM PRATENSE POLLEN; AMARANTHUS RETROFLEXUS POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA TOMENTOSA POLLEN
• Active Ingredient Strength: 400 [AU]/mL; [AU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL
• Pharm Classes: 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],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],Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect 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],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],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],Increased IgG Production [PE],Pollen [CS],Allergens [CS]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 49288-0811-3

10 mL in 1 VIAL, MULTI-DOSE (49288-0811-3)

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

NDC SPL Data Element Entries

NDC 49288-0811-3 [49288081103]

Treatment Set TS340796 INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102223
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1986-10-31
• Inactivation Date: 2019-10-29

Drug Details

Active Ingredients

Ingredient	Strength
DERMATOPHAGOIDES FARINAE	400 [AU]/mL

OpenFDA Data

• SPL SET ID: f6860af7-50de-4142-b8e2-bf5fc0d7d498
• Manufacturer:
  • Antigen Laboratories, Inc.
• UNII:
  • E03U1K03LK
  • 700NK45C76
  • PR9U2YPF3Q
  • A0WFQ8P6N1
  • 3R393IX840
  • 95447163DG
  • 1564HD0N96
  • 098LKX5NCN
  • 93963RFO1P
  • 89BAT511BD
  • Z4Y9ZSV4KK
  • 23H70FYJ5U
  • G684LX721Q
  • DO87T1U2CI
  • PYO4JR720Y
  • K20Y81ACO3
  • 65M88RW2EG
  • R889N2L976
  • JQ5HI5004M
  • 175F461W10
  • 3538FNV8AY
  • V825XJG64G
  • N52MIQ81ZW
  • 8KDG09A4GO
  • EYO007VX98
  • 57L1Z5378K
  • 2MH135KC6G
  • SVW19ET93C
  • 05S7L91ZTR
  • 1BV28146ZR
  • KU1V1898XX
  • 2RQ1L9N089
  • V38QUQ7861
  • 476DVV63WP
  • 4T81LB52R0
  • 73B14PX5FW

Pharmacological Class

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