Treatment Set TS344570

Product NDC
49288-0837
11-digit product format
492880837
Labeler code
49288
Product ID
49288-0837_3d2e8502-9a04-4060-a553-26e1bf285501
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Treatment Set TS344570
Dosage form
INJECTION, SOLUTION
Route
INTRADERMAL; SUBCUTANEOUS
Labeler
Antigen Laboratories, Inc.
Application
BLA102223
Marketing category
BLA
Marketing start
1986-10-31
Marketing end
0000-00-00
Substance
FELIS CATUS HAIR; DERMATOPHAGOIDES FARINAE; ALTERNARIA ALTERNATA; DERMATOPHAGOIDES PTERONYSSINUS; AMBROSIA ARTEMISIIFOLIA POLLEN; SORGHUM HALEPENSE POLLEN; PASCOPYRUM SMITHII POLLEN; FRAXINUS AMERICANA POLLEN; QUERCUS ALBA POLLEN
Active strength
400 [BAU]/mL; [AU]/mL; g/mL; [AU]/mL; [AU]/mL; g/mL; g/mL; g/mL; g/mL
Pharmacologic classes
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 Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS],Insect Proteins [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],Allergens [CS],Insect Proteins [CS],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49288-0837-32019-11-13C16284748780-197449f38-b93c-f6ea-e053-dbdaa90aa703ALLERGENIC EXTRACTS INDIVIDUAL TREATMENT VIAL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49288-0837-3Treatment Set TS34457010 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION101

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALTERNARIA ALTERNATAACTIVE INGREDIENT52B29REC7HTREATMENT SET TS344558 INJECTION, SOLUTION TREATMENT SET TS344570 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
AMBROSIA ARTEMISIIFOLIA POLLENACTIVE INGREDIENTK20Y81ACO3TREATMENT SET TS344558 INJECTION, SOLUTION TREATMENT SET TS344570 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
ASPERGILLUS FUMIGATUSACTIVE INGREDIENTX88DF51T48TREATMENT SET TS344558 INJECTION, SOLUTION TREATMENT SET TS344570 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
AUREOBASIDIUM PULLULANS VAR. PULLUTANSACTIVE INGREDIENTD1A2NG69CKTREATMENT SET TS344558 INJECTION, SOLUTION TREATMENT SET TS344570 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
CLADOSPORIUM CLADOSPORIOIDESACTIVE INGREDIENT4ZWY20GTGOTREATMENT SET TS344558 INJECTION, SOLUTION TREATMENT SET TS344570 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
COCHLIOBOLUS SATIVUSACTIVE INGREDIENT3LN5B70U4WTREATMENT SET TS344558 INJECTION, SOLUTION TREATMENT SET TS344570 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
DERMATOPHAGOIDES FARINAEACTIVE INGREDIENTPR9U2YPF3QTREATMENT SET TS344558 INJECTION, SOLUTION TREATMENT SET TS344570 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
DERMATOPHAGOIDES PTERONYSSINUSACTIVE INGREDIENT57L1Z5378KTREATMENT SET TS344558 INJECTION, SOLUTION TREATMENT SET TS344570 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
FELIS CATUS HAIRACTIVE INGREDIENT1564HD0N96TREATMENT SET TS344558 INJECTION, SOLUTION TREATMENT SET TS344570 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
FRAXINUS AMERICANA POLLENACTIVE INGREDIENTG684LX721QTREATMENT SET TS344558 INJECTION, SOLUTION TREATMENT SET TS344570 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
FUSARIUM OXYSPORUMACTIVE INGREDIENT5398RXP8KUTREATMENT SET TS344558 INJECTION, SOLUTION TREATMENT SET TS344570 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
PASCOPYRUM SMITHII POLLENACTIVE INGREDIENT6AU0ZD8T1OTREATMENT SET TS344558 INJECTION, SOLUTION TREATMENT SET TS344570 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUMACTIVE INGREDIENT3Y1PE1GCIGTREATMENT SET TS344558 INJECTION, SOLUTION TREATMENT SET TS344570 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
PHOMA DESTRUCTIVAACTIVE INGREDIENTA17SE577FMTREATMENT SET TS344558 INJECTION, SOLUTION TREATMENT SET TS344570 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
QUERCUS ALBA POLLENACTIVE INGREDIENTZ4Y9ZSV4KKTREATMENT SET TS344558 INJECTION, SOLUTION TREATMENT SET TS344570 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
RHIZOPUS STOLONIFERACTIVE INGREDIENTFEE198DK4QTREATMENT SET TS344558 INJECTION, SOLUTION TREATMENT SET TS344570 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
SORGHUM HALEPENSE POLLENACTIVE INGREDIENT577VA5B4HPTREATMENT SET TS344558 INJECTION, SOLUTION TREATMENT SET TS344570 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
ALTERNARIA ALTERNATAACTIVE MOIETY52B29REC7HTREATMENT SET TS344558 INJECTION, SOLUTION TREATMENT SET TS344570 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
AMBROSIA ARTEMISIIFOLIA POLLENACTIVE MOIETYK20Y81ACO3TREATMENT SET TS344558 INJECTION, SOLUTION TREATMENT SET TS344570 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
ASPERGILLUS FUMIGATUSACTIVE MOIETYX88DF51T48TREATMENT SET TS344558 INJECTION, SOLUTION TREATMENT SET TS344570 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
AUREOBASIDIUM PULLULANS VAR. PULLUTANSACTIVE MOIETYD1A2NG69CKTREATMENT SET TS344558 INJECTION, SOLUTION TREATMENT SET TS344570 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
CLADOSPORIUM CLADOSPORIOIDESACTIVE MOIETY4ZWY20GTGOTREATMENT SET TS344558 INJECTION, SOLUTION TREATMENT SET TS344570 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
COCHLIOBOLUS SATIVUSACTIVE MOIETY3LN5B70U4WTREATMENT SET TS344558 INJECTION, SOLUTION TREATMENT SET TS344570 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
DERMATOPHAGOIDES FARINAEACTIVE MOIETYPR9U2YPF3QTREATMENT SET TS344558 INJECTION, SOLUTION TREATMENT SET TS344570 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
DERMATOPHAGOIDES PTERONYSSINUSACTIVE MOIETY57L1Z5378KTREATMENT SET TS344558 INJECTION, SOLUTION TREATMENT SET TS344570 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
FELIS CATUS HAIRACTIVE MOIETY1564HD0N96TREATMENT SET TS344558 INJECTION, SOLUTION TREATMENT SET TS344570 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
FRAXINUS AMERICANA POLLENACTIVE MOIETYG684LX721QTREATMENT SET TS344558 INJECTION, SOLUTION TREATMENT SET TS344570 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
FUSARIUM OXYSPORUMACTIVE MOIETY5398RXP8KUTREATMENT SET TS344558 INJECTION, SOLUTION TREATMENT SET TS344570 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
PASCOPYRUM SMITHII POLLENACTIVE MOIETY6AU0ZD8T1OTREATMENT SET TS344558 INJECTION, SOLUTION TREATMENT SET TS344570 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUMACTIVE MOIETY3Y1PE1GCIGTREATMENT SET TS344558 INJECTION, SOLUTION TREATMENT SET TS344570 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
PHOMA DESTRUCTIVAACTIVE MOIETYA17SE577FMTREATMENT SET TS344558 INJECTION, SOLUTION TREATMENT SET TS344570 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
QUERCUS ALBA POLLENACTIVE MOIETYZ4Y9ZSV4KKTREATMENT SET TS344558 INJECTION, SOLUTION TREATMENT SET TS344570 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
RHIZOPUS STOLONIFERACTIVE MOIETYFEE198DK4QTREATMENT SET TS344558 INJECTION, SOLUTION TREATMENT SET TS344570 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
SORGHUM HALEPENSE POLLENACTIVE MOIETY577VA5B4HPTREATMENT SET TS344558 INJECTION, SOLUTION TREATMENT SET TS344570 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTREATMENT SET TS344558 INJECTION, SOLUTION TREATMENT SET TS344570 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
PHENOLINACTIVE INGREDIENT339NCG44TVTREATMENT SET TS344558 INJECTION, SOLUTION TREATMENT SET TS344570 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOTREATMENT SET TS344558 INJECTION, SOLUTION TREATMENT SET TS344570 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XTREATMENT SET TS344558 INJECTION, SOLUTION TREATMENT SET TS344570 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RTREATMENT SET TS344558 INJECTION, SOLUTION TREATMENT SET TS344570 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49288-0837TREATMENT SET TS344558 INJECTION, SOLUTION TREATMENT SET TS344570 INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]1Legacy NDC, 1 package rows20120120_a2a38721-f395-4aeb-927b-35c959ce586e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
49288-0837-34928808370310 mL in 1 VIAL, MULTI-DOSE10 mlHistorical