NDC 49288-0804

Treatment Set TS339992

Treatment Set Ts339992

Treatment Set TS339992 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; Iva Annua Var. Annua Pollen; Juniperus Ashei Pollen; Phleum Pratense Pollen; Ambrosia Artemisiifolia Pollen; Ulmus Americana Pollen; Acer Negundo Pollen.

• Product ID: 49288-0804_604c0704-1a4c-431a-9876-de77f5f3882c
• NDC: 49288-0804
• Product Type: Human Prescription Drug
• Proprietary Name: Treatment Set TS339992
• Generic Name: Treatment Set Ts339992
• 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; IVA ANNUA VAR. ANNUA POLLEN; JUNIPERUS ASHEI POLLEN; PHLEUM PRATENSE POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ULMUS AMERICANA POLLEN; ACER NEGUNDO POLLEN
• Active Ingredient Strength: 400 [AU]/mL; [AU]/mL; [BAU]/mL; g/mL; g/mL; [BAU]/mL; [AU]/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],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],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],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 49288-0804-3

10 mL in 1 VIAL, MULTI-DOSE (49288-0804-3)

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

NDC SPL Data Element Entries

NDC 49288-0804-3 [49288080403]

Treatment Set TS339992 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 PTERONYSSINUS	400 [AU]/mL

OpenFDA Data

• SPL SET ID: e50fbed1-a782-44a7-ace6-3a0d9e4a3a8e
• Manufacturer:
  • Antigen Laboratories, Inc.
• UNII:
  • 23H70FYJ5U
  • D1A2NG69CK
  • 098LKX5NCN
  • 9Y53ZS6I82
  • GQM6LVU5V8
  • G2A764T54B
  • 3Y1PE1GCIG
  • 4K7Z7K7SWG
  • 1564HD0N96
  • G684LX721Q
  • A17SE577FM
  • 93963RFO1P
  • 89BAT511BD
  • V003SHB7VK
  • 577VA5B4HP
  • Z4Y9ZSV4KK
  • 65M88RW2EG
  • BV82OL2IZ8
  • DO87T1U2CI
  • 52B29REC7H
  • PYO4JR720Y
  • P6K070AR8V
  • KU1V1898XX
  • PY0JA16R2G
  • PR9U2YPF3Q
  • YIH315U1TU
  • 57L1Z5378K
  • K20Y81ACO3
  • RX18M46K8L
  • X88DF51T48
  • 1FCM16V0FV
  • FEE198DK4Q
  • 0N3Z1P4B2W
  • 15XI414745
  • 544F8MEY0Y
  • 2MH135KC6G
  • SCB8J7LS3T
  • 4ZWY20GTGO
  • 83B65P4796
  • 175F461W10
  • 05S7L91ZTR
  • 3LN5B70U4W
  • 2RQ1L9N089
  • A0WFQ8P6N1
  • 4D7G21HDBC
  • 476DVV63WP
  • 0V3J4YEX2W
  • 73B14PX5FW
• 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]
• 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]
• 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]
• 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]