NDC 49288-0789

Treatment Set TS336683

Treatment Set Ts336683

Treatment Set TS336683 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 Betula Populifolia Pollen; Ulmus Americana Pollen; Acer Rubrum Pollen; Quercus Alba Pollen; Populus Deltoides Pollen; Juniperus Virginiana Pollen; Carya Illinoinensis Pollen; Fraxinus Americana Pollen; Ambrosia Artemisiifolia Pollen; Plantago Lanceolata Pollen; Chenopodium Album Pollen; Iva Annua Var. Annua Pollen; Amaranthus Retroflexus Pollen; Salsola Kali Pollen; Rumex Acetosella Pollen.

• Product ID: 49288-0789_b4053499-e3af-4991-9c56-5eb96ac94dca
• NDC: 49288-0789
• Product Type: Human Prescription Drug
• Proprietary Name: Treatment Set TS336683
• Generic Name: Treatment Set Ts336683
• 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: BETULA POPULIFOLIA POLLEN; ULMUS AMERICANA POLLEN; ACER RUBRUM POLLEN; QUERCUS ALBA POLLEN; POPULUS DELTOIDES POLLEN; JUNIPERUS VIRGINIANA POLLEN; CARYA ILLINOINENSIS POLLEN; FRAXINUS AMERICANA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; PLANTAGO LANCEOLATA POLLEN; CHENOPODIUM ALBUM POLLEN; IVA ANNUA VAR. ANNUA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; SALSOLA KALI POLLEN; RUMEX ACETOSELLA POLLEN
• Active Ingredient Strength: 0 g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; [AU]/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],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-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],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],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],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Increased Histamine Release [PE],Allergens [CS]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 49288-0789-3

10 mL in 1 VIAL, MULTI-DOSE (49288-0789-3)

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

NDC SPL Data Element Entries

NDC 49288-0789-3 [49288078903]

Treatment Set TS336683 INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102223
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1986-10-31
• Inactivation Date: 2019-10-21

Drug Details

Active Ingredients

Ingredient	Strength
BETULA POPULIFOLIA POLLEN	.000016 g/mL

OpenFDA Data

• SPL SET ID: 400bff34-d1a7-420e-9635-3119313cea5e
• Manufacturer:
  • Antigen Laboratories, Inc.
• UNII:
  • 23H70FYJ5U
  • 700NK45C76
  • 1564HD0N96
  • 098LKX5NCN
  • 89BAT511BD
  • V003SHB7VK
  • 577VA5B4HP
  • Z4Y9ZSV4KK
  • G684LX721Q
  • DO87T1U2CI
  • PYO4JR720Y
  • 83N78IDA7P
  • PY0JA16R2G
  • PR9U2YPF3Q
  • 65M88RW2EG
  • K20Y81ACO3
  • SCB8J7LS3T
  • 175F461W10
  • FEE198DK4Q
  • 57L1Z5378K
  • 2MH135KC6G
  • N52MIQ81ZW
  • 05S7L91ZTR
  • 52B29REC7H
  • 476DVV63WP
  • 4T81LB52R0
  • 73B14PX5FW

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