NDC 49288-0825

Treatment Set TS343826

Treatment Set Ts343826

Treatment Set TS343826 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 Sorghum Halepense Pollen; Ambrosia Trifida Pollen; Ambrosia Artemisiifolia Pollen; Ulmus Americana Pollen; Plantago Lanceolata Pollen; Fraxinus Americana Pollen; Amaranthus Retroflexus Pollen; Salsola Kali Pollen; Kochia Scoparia Pollen; Chenopodium Album Pollen; Lolium Perenne Pollen; Platanus Occidentalis Pollen; Artemisia Vulgaris Pollen; Iva Axillaris Pollen; Populus Nigra Pollen; Populus Alba Pollen; Quercus Virginiana Pollen; Quercus Rubra Pollen; Quercus Alba Pollen.

• Product ID: 49288-0825_bb49432e-682e-4b49-8a8e-a6f9eddd7bfc
• NDC: 49288-0825
• Product Type: Human Prescription Drug
• Proprietary Name: Treatment Set TS343826
• Generic Name: Treatment Set Ts343826
• 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: SORGHUM HALEPENSE POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; ULMUS AMERICANA POLLEN; PLANTAGO LANCEOLATA POLLEN; FRAXINUS AMERICANA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; KOCHIA SCOPARIA POLLEN; CHENOPODIUM ALBUM POLLEN; LOLIUM PERENNE POLLEN; PLATANUS OCCIDENTALIS POLLEN; ARTEMISIA VULGARIS POLLEN; IVA AXILLARIS POLLEN; POPULUS NIGRA POLLEN; POPULUS ALBA POLLEN; QUERCUS VIRGINIANA POLLEN; QUERCUS RUBRA POLLEN; QUERCUS ALBA POLLEN
• Active Ingredient Strength: 0 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/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],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [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],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],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],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 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 49288-0825-3

10 mL in 1 VIAL, MULTI-DOSE (49288-0825-3)

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

NDC SPL Data Element Entries

NDC 49288-0825-3 [49288082503]

Treatment Set TS343826 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
SORGHUM HALEPENSE POLLEN	.003 g/mL

OpenFDA Data

• SPL SET ID: e26adce8-a53d-4d04-ab66-6de34d1e8bc4
• Manufacturer:
  • Antigen Laboratories, Inc.
• UNII:
  • E03U1K03LK
  • 23H70FYJ5U
  • A0WFQ8P6N1
  • O64JF11198
  • 52B29REC7H
  • 1564HD0N96
  • 4F35XG0149
  • 098LKX5NCN
  • 89BAT511BD
  • 6AU0ZD8T1O
  • 577VA5B4HP
  • Z4Y9ZSV4KK
  • DO87T1U2CI
  • G684LX721Q
  • A7IKY24TR7
  • KU1V1898XX
  • 0MGE63QPFJ
  • PYO4JR720Y
  • P6K070AR8V
  • VU8C8SB23P
  • PY0JA16R2G
  • PR9U2YPF3Q
  • 2RQ1L9N089
  • 65M88RW2EG
  • K20Y81ACO3
  • X88DF51T48
  • 5398RXP8KU
  • N52MIQ81ZW
  • 8KDG09A4GO
  • 57L1Z5378K
  • 2MH135KC6G
  • SVW19ET93C
  • 4ZWY20GTGO
  • DNB59M1NVU
  • 175F461W10
  • 05S7L91ZTR
  • ANT994T71D
  • 3LN5B70U4W
  • 13KFG30UBR
  • 476DVV63WP
  • 73B14PX5FW
  • 4T81LB52R0
  • 3Y1PE1GCIG

Pharmacological Class

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