NDC 49288-0839

Treatment Set TS344801

Treatment Set Ts344801

Treatment Set TS344801 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 Acer Negundo Pollen; Ambrosia Artemisiifolia Pollen; Carya Illinoinensis Pollen; Iva Annua Var. Annua Pollen; Carya Tomentosa Pollen; Juglans Nigra Pollen; Canis Lupus Familiaris Hair; Felis Catus Hair.

• Product ID: 49288-0839_9a8e59e8-156a-4999-a000-b68054b405d3
• NDC: 49288-0839
• Product Type: Human Prescription Drug
• Proprietary Name: Treatment Set TS344801
• Generic Name: Treatment Set Ts344801
• 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: ACER NEGUNDO POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; CARYA ILLINOINENSIS POLLEN; IVA ANNUA VAR. ANNUA POLLEN; CARYA TOMENTOSA POLLEN; JUGLANS NIGRA POLLEN; CANIS LUPUS FAMILIARIS HAIR; FELIS CATUS HAIR
• Active Ingredient Strength: 0 g/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL
• Pharm Classes: 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],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],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 Animal Hair Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Animal Fur [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]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 49288-0839-3

10 mL in 1 VIAL, MULTI-DOSE (49288-0839-3)

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

NDC SPL Data Element Entries

NDC 49288-0839-3 [49288083903]

Treatment Set TS344801 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
ACER NEGUNDO POLLEN	.002 g/mL

OpenFDA Data

• SPL SET ID: 354ef6d9-c531-4958-bc94-00e52569c0e1
• Manufacturer:
  • Antigen Laboratories, Inc.
• UNII:
  • 23H70FYJ5U
  • D1A2NG69CK
  • 098LKX5NCN
  • 9Y53ZS6I82
  • GQM6LVU5V8
  • 3Y1PE1GCIG
  • 52B29REC7H
  • 4K7Z7K7SWG
  • 1564HD0N96
  • G684LX721Q
  • 93963RFO1P
  • 89BAT511BD
  • 6AU0ZD8T1O
  • 577VA5B4HP
  • 55W4M8149I
  • BV82OL2IZ8
  • DO87T1U2CI
  • KU1V1898XX
  • PYO4JR720Y
  • P6K070AR8V
  • PY0JA16R2G
  • PR9U2YPF3Q
  • 2RQ1L9N089
  • Z4Y9ZSV4KK
  • K20Y81ACO3
  • RX18M46K8L
  • X88DF51T48
  • 1FCM16V0FV
  • FEE198DK4Q
  • 0N3Z1P4B2W
  • 15XI414745
  • O64JF11198
  • 57L1Z5378K
  • 2MH135KC6G
  • N52MIQ81ZW
  • A17SE577FM
  • SCB8J7LS3T
  • 4ZWY20GTGO
  • 83B65P4796
  • 175F461W10
  • 05S7L91ZTR
  • 1BV28146ZR
  • 3LN5B70U4W
  • YIH315U1TU
  • 4D7G21HDBC
  • 476DVV63WP
  • 0V3J4YEX2W
  • 73B14PX5FW
• RxNorm Concept Unique ID - RxCUI:
  • 1248605
  • 1248595
• 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

• 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]
• 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]
• 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 Animal Hair Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Animal Fur [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]