NDC 49288-0675

Treatment Set TS128811

Treatment Set Ts128811

Treatment Set TS128811 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 Fraxinus Pennsylvanica Pollen; Fraxinus Americana Pollen; Poa Pratensis Pollen; Festuca Pratensis Pollen; Dactylis Glomerata Pollen; Lolium Perenne Pollen; Agrostis Gigantea Pollen; Anthoxanthum Odoratum Pollen; Anthoxanthum Odoratum Pollen; Ulmus Americana Pollen; Juniperus Virginiana Pollen; Acer Negundo Pollen; Juglans Nigra Pollen.

Product ID	49288-0675_89f9e682-acd9-4cc7-982d-c32f69b33b07
NDC	49288-0675
Product Type	Human Prescription Drug
Proprietary Name	Treatment Set TS128811
Generic Name	Treatment Set Ts128811
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	FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS AMERICANA POLLEN; POA PRATENSIS POLLEN; FESTUCA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; LOLIUM PERENNE POLLEN; AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; ANTHOXANTHUM ODORATUM POLLEN; ULMUS AMERICANA POLLEN; JUNIPERUS VIRGINIANA POLLEN; ACER NEGUNDO POLLEN; JUGLANS NIGRA POLLEN
Active Ingredient Strength	0 g/mL; g/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/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],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],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],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],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 49288-0675-3

10 mL in 1 VIAL, MULTI-DOSE (49288-0675-3)

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

NDC SPL Data Element Entries

NDC 49288-0675-3 [49288067503]

Treatment Set TS128811 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
FRAXINUS PENNSYLVANICA POLLEN	.0025 g/mL

OpenFDA Data

SPL SET ID:	ed4d2a22-6a86-48b6-97c0-7774c659120f
Manufacturer	Antigen Laboratories, Inc.
UNII	E03U1K03LK FEE198DK4Q 3F36V0451W Y0M7LGE3Z8 4K7Z7K7SWG 4F35XG0149 68R9X9Y96X A17SE577FM 2VWV12V9WR 380W4HYR6N SQ89E6LOME G0O5980Z7W 577VA5B4HP HJ4L70T1ZP 098LKX5NCN 9Y53ZS6I82 B7B86Y84R8 34X886W1H4 KSY1AWN59I P6K070AR8V YI19RB8YFD 87U156LEN7 Z4Y9ZSV4KK RX18M46K8L X88DF51T48 Q4T1SJ3046 F1KAH8374D RZ55S3AQOJ M3S672G75O I6KAZ8AO1O 3J888Y9L13 WIB701MW2H N4F4RQ7BY7 3538FNV8AY N52MIQ81ZW 57KIJ4772H 2RQ1L9N089 Z4MD1809H1 B55BD1QM4Q 91M9RWP3TD D1A2NG69CK 1X92VM01YP GQM6LVU5V8 92N6W6KO2G O64JF11198 95447163DG TGO054E31O 2147EPR64I T8678F0P0Q C91ZMT66YA 6M2JIH93ZN G684LX721Q 83N78IDA7P VU8C8SB23P PR9U2YPF3Q 50HCQ1NYV5 2KIK19R45Y K20Y81ACO3 5Q246DS5BS 81GS97HVFO S8A4X05W7J 5398RXP8KU T069R9OPVG 4D7G21HDBC 57L1Z5378K 2MH135KC6G 341PDX5PLM DHI513VXU7 6AU0ZD8T1O 52B29REC7H YIH315U1TU V38QUQ7861 476DVV63WP 23H70FYJ5U 74PD8J616H 3I9T68187H HR6H5057CO KO7V58BY40 G2A764T54B 2A64U81OQ3 ON2T85TA2O TX1ER5UV3T TOQ97Z8644 7Q7T9Z7QUW 16M9MK8C4W 17RH99LQ7G DO87T1U2CI 9UC4BM3IZ0 9LYI4RTZ52 7ORP6R724L 2WZG2G15WX 70O1TP6H01 49VI1ZSO06 R9JBC6687X SCB8J7LS3T 175F461W10 1GH3WV23KH HU8V6E7HOA 4ZWY20GTGO DNB59M1NVU ANT994T71D 15XI414745 0V3J4YEX2W 7X8HL8GRTM 4T81LB52R0 AZJ5XKM7W3 700NK45C76 W5U19AK212 FAY1Y90VJ9 A0WFQ8P6N1 3Y1PE1GCIG 41Y752Y34M 1564HD0N96 6K41G30A6U 93963RFO1P 89BAT511BD 65M88RW2EG BV82OL2IZ8 KU1V1898XX PYO4JR720Y PY0JA16R2G 1XSC3BB35Z 766QT72BK6 9IOA40ANG6 V825XJG64G X92O101CS2 0N3Z1P4B2W 544F8MEY0Y VK8C112WTS 83B65P4796 05S7L91ZTR 1BV28146ZR 3LN5B70U4W H20KU95UBG 54UN9R2798 1M4E76V32I 1FCM16V0FV 73B14PX5FW
RxNorm Concept Unique ID - RxCUI	1192833 1192780 1191210
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]
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]
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]
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]
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]