NDC 49288-0848

Treatment Set TS345463

Treatment Set Ts345463

Treatment Set TS345463 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 Cynodon Dactylon Pollen; Carya Illinoinensis Pollen; Carya Tomentosa Pollen; Amaranthus Retroflexus Pollen; Ambrosia Artemisiifolia Pollen; Rumex Acetosella Pollen; Avena Sativa Pollen; Phleum Pratense Pollen; Pascopyrum Smithii Pollen; Periplaneta Americana.

• Product ID: 49288-0848_bfb6bdbb-da65-4cb3-a50d-250270cdd448
• NDC: 49288-0848
• Product Type: Human Prescription Drug
• Proprietary Name: Treatment Set TS345463
• Generic Name: Treatment Set Ts345463
• 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: CYNODON DACTYLON POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA TOMENTOSA POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; RUMEX ACETOSELLA POLLEN; AVENA SATIVA POLLEN; PHLEUM PRATENSE POLLEN; PASCOPYRUM SMITHII POLLEN; PERIPLANETA AMERICANA
• Active Ingredient Strength: 16 [BAU]/mL; g/mL; g/mL; g/mL; [AU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL
• Pharm Classes: 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],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],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Increased Histamine Release [PE],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 Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [CS],Allergens [CS]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 49288-0848-3

10 mL in 1 VIAL, MULTI-DOSE (49288-0848-3)

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

NDC SPL Data Element Entries

NDC 49288-0848-3 [49288084803]

Treatment Set TS345463 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
CYNODON DACTYLON POLLEN	16 [BAU]/mL

OpenFDA Data

• SPL SET ID: 40631eff-c151-4f94-ade6-6ad2eaced01a
• Manufacturer:
  • Antigen Laboratories, Inc.
• UNII:
  • E03U1K03LK
  • 23H70FYJ5U
  • 3I9T68187H
  • A0WFQ8P6N1
  • 3Y1PE1GCIG
  • 1564HD0N96
  • 4F35XG0149
  • 098LKX5NCN
  • Y2U5S5PF22
  • 89BAT511BD
  • 6AU0ZD8T1O
  • 577VA5B4HP
  • Z4Y9ZSV4KK
  • 65M88RW2EG
  • DO87T1U2CI
  • G684LX721Q
  • A7IKY24TR7
  • PYO4JR720Y
  • P6K070AR8V
  • PY0JA16R2G
  • PR9U2YPF3Q
  • 544F8MEY0Y
  • K20Y81ACO3
  • 81GS97HVFO
  • SCB8J7LS3T
  • 175F461W10
  • 0N3Z1P4B2W
  • 57L1Z5378K
  • 2MH135KC6G
  • N52MIQ81ZW
  • DNB59M1NVU
  • 05S7L91ZTR
  • 52B29REC7H
  • 2RQ1L9N089
  • 476DVV63WP
  • 73B14PX5FW

Pharmacological Class

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