Chaetomium
Allergenic Extract
Approved
Approval ID
6d2006e2-55ea-41db-bd17-ce6d080f28a0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 17, 2009
Manufacturers
FDA
Antigen Laboratories, Inc.
DUNS: 030705628
Products 10
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Phycomyces
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0373
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Phycomyces
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 17, 2009
FDA Product Classification
INGREDIENTS (5)
PHYCOMYCES BLAKESLEEANUSActive
Quantity: 0.05 g in 1 mL
Code: 41Y752Y34M
Classification: ACTIB
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Penicillium notatum
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0416
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Penicillium notatum
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 17, 2009
FDA Product Classification
INGREDIENTS (5)
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUMActive
Quantity: 0.1 g in 1 mL
Code: 3Y1PE1GCIG
Classification: ACTIB
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
C Mold Mixture
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0091
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
C Mold Mixture
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateNovember 17, 2009
FDA Product Classification
INGREDIENTS (16)
VERTICILLIUM ALBO-ATRUMActive
Quantity: 0.0042 g in 1 mL
Code: X92O101CS2
Classification: ACTIB
MYCOCLADUS CORYMBIFERUSActive
Quantity: 0.0042 g in 1 mL
Code: 1M4E76V32I
Classification: ACTIB
HUMICOLA GRISEAActive
Quantity: 0.0042 g in 1 mL
Code: RZ55S3AQOJ
Classification: ACTIB
ACROTHECIUM ROBUSTUMActive
Quantity: 0.0042 g in 1 mL
Code: C91ZMT66YA
Classification: ACTIB
MICROSPORUM AUDOUINIIActive
Quantity: 0.0042 g in 1 mL
Code: B7B86Y84R8
Classification: ACTIB
MICROSPORUM CANISActive
Quantity: 0.0042 g in 1 mL
Code: N4F4RQ7BY7
Classification: ACTIB
STACHYBOTRYS CHARTARUMActive
Quantity: 0.0042 g in 1 mL
Code: HJ4L70T1ZP
Classification: ACTIB
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
APIOSPORA MONTAGNEIActive
Quantity: 0.0042 g in 1 mL
Code: 49VI1ZSO06
Classification: ACTIB
SPOROTRICHUM PRUINOSUMActive
Quantity: 0.0042 g in 1 mL
Code: H20KU95UBG
Classification: ACTIB
TETRACOCCOSPORIUM PAXIANUMActive
Quantity: 0.0042 g in 1 mL
Code: KSY1AWN59I
Classification: ACTIB
PHYCOMYCES BLAKESLEEANUSActive
Quantity: 0.0042 g in 1 mL
Code: 41Y752Y34M
Classification: ACTIB
SYNCEPHALASTRUM RACEMOSUMActive
Quantity: 0.0042 g in 1 mL
Code: 2VWV12V9WR
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
C Mold Mixture
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0092
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
C Mold Mixture
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateNovember 17, 2009
FDA Product Classification
INGREDIENTS (16)
APIOSPORA MONTAGNEIActive
Quantity: 0.0021 g in 1 mL
Code: 49VI1ZSO06
Classification: ACTIB
MYCOCLADUS CORYMBIFERUSActive
Quantity: 0.0021 g in 1 mL
Code: 1M4E76V32I
Classification: ACTIB
ACROTHECIUM ROBUSTUMActive
Quantity: 0.0021 g in 1 mL
Code: C91ZMT66YA
Classification: ACTIB
HUMICOLA GRISEAActive
Quantity: 0.0021 g in 1 mL
Code: RZ55S3AQOJ
Classification: ACTIB
MICROSPORUM AUDOUINIIActive
Quantity: 0.0021 g in 1 mL
Code: B7B86Y84R8
Classification: ACTIB
MICROSPORUM CANISActive
Quantity: 0.0021 g in 1 mL
Code: N4F4RQ7BY7
Classification: ACTIB
PHYCOMYCES BLAKESLEEANUSActive
Quantity: 0.0021 g in 1 mL
Code: 41Y752Y34M
Classification: ACTIB
SPOROTRICHUM PRUINOSUMActive
Quantity: 0.0021 g in 1 mL
Code: H20KU95UBG
Classification: ACTIB
STACHYBOTRYS CHARTARUMActive
Quantity: 0.0021 g in 1 mL
Code: HJ4L70T1ZP
Classification: ACTIB
SYNCEPHALASTRUM RACEMOSUMActive
Quantity: 0.0021 g in 1 mL
Code: 2VWV12V9WR
Classification: ACTIB
TETRACOCCOSPORIUM PAXIANUMActive
Quantity: 0.0021 g in 1 mL
Code: KSY1AWN59I
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
VERTICILLIUM ALBO-ATRUMActive
Quantity: 0.0021 g in 1 mL
Code: X92O101CS2
Classification: ACTIB
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
C Mold Mixture
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0090
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
C Mold Mixture
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateNovember 17, 2009
FDA Product Classification
INGREDIENTS (16)
MICROSPORUM CANISActive
Quantity: 0.0083 g in 1 mL
Code: N4F4RQ7BY7
Classification: ACTIB
APIOSPORA MONTAGNEIActive
Quantity: 0.0083 g in 1 mL
Code: 49VI1ZSO06
Classification: ACTIB
ACROTHECIUM ROBUSTUMActive
Quantity: 0.0083 g in 1 mL
Code: C91ZMT66YA
Classification: ACTIB
STACHYBOTRYS CHARTARUMActive
Quantity: 0.0083 g in 1 mL
Code: HJ4L70T1ZP
Classification: ACTIB
MYCOCLADUS CORYMBIFERUSActive
Quantity: 0.0083 g in 1 mL
Code: 1M4E76V32I
Classification: ACTIB
HUMICOLA GRISEAActive
Quantity: 0.0083 g in 1 mL
Code: RZ55S3AQOJ
Classification: ACTIB
MICROSPORUM AUDOUINIIActive
Quantity: 0.0083 g in 1 mL
Code: B7B86Y84R8
Classification: ACTIB
TETRACOCCOSPORIUM PAXIANUMActive
Quantity: 0.0083 g in 1 mL
Code: KSY1AWN59I
Classification: ACTIB
PHYCOMYCES BLAKESLEEANUSActive
Quantity: 0.0083 g in 1 mL
Code: 41Y752Y34M
Classification: ACTIB
SPOROTRICHUM PRUINOSUMActive
Quantity: 0.0083 g in 1 mL
Code: H20KU95UBG
Classification: ACTIB
SYNCEPHALASTRUM RACEMOSUMActive
Quantity: 0.0083 g in 1 mL
Code: 2VWV12V9WR
Classification: ACTIB
VERTICILLIUM ALBO-ATRUMActive
Quantity: 0.0083 g in 1 mL
Code: X92O101CS2
Classification: ACTIB
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Humicola grisea
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0635
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Humicola grisea
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateNovember 17, 2009
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
HUMICOLA GRISEAActive
Quantity: 0.05 g in 1 mL
Code: RZ55S3AQOJ
Classification: ACTIB
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
Neurospora intermedia
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0326
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Neurospora intermedia
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 17, 2009
FDA Product Classification
INGREDIENTS (5)
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
NEUROSPORA INTERMEDIAActive
Quantity: 0.05 g in 1 mL
Code: 2072U60DUI
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
Mucor plumbeus
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0638
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Mucor plumbeus
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 17, 2009
FDA Product Classification
INGREDIENTS (5)
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
MUCOR PLUMBEUSActive
Quantity: 0.05 g in 1 mL
Code: D7401PWY6E
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Penicillium camembertii
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0648
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Penicillium camembertii
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 17, 2009
FDA Product Classification
INGREDIENTS (5)
PENICILLIUM CAMEMBERTIActive
Quantity: 0.05 g in 1 mL
Code: T069R9OPVG
Classification: ACTIB
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
Penicillium chrysogenum
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49288-0649
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Penicillium chrysogenum
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 17, 2009
FDA Product Classification
INGREDIENTS (5)
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUMActive
Quantity: 0.05 g in 1 mL
Code: 3Y1PE1GCIG
Classification: ACTIB
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Drug Labeling Information
BOXED WARNING SECTION
LOINC: 34066-1Updated: 11/17/2009