Standardized Mite Dermatophagoides farinae
These highlights do not include all the information needed to use Greer Standardized Mite Extracts safely and effectively. See full prescribing information for Greer Standardized Mite Extracts. Standardized Mite Extract ( ) Standardized Mite Extract ( ) Standardized Mite Extract Mixture ( and ) Solution for percutaneous, intradermal, or subcutaneous administration Initial U.S. Approval: 1987
Approved
Approval ID
9b7f878e-613f-4831-9223-a6a07fb09f1b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 7, 2019
Manufacturers
FDA
Greer Laboratories, Inc.
DUNS: 024671414
Products 8
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dermatophagoides pteronyssinus
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code22840-0036
Application NumberBLA101835
Product Classification
M
Marketing Category
C73585
G
Generic Name
Dermatophagoides pteronyssinus
Product Specifications
Route of AdministrationINTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS
Effective DateOctober 7, 2019
FDA Product Classification
INGREDIENTS (5)
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
DERMATOPHAGOIDES PTERONYSSINUSActive
Quantity: 10000 [AU] in 1 mL
Code: 57L1Z5378K
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
Dermatophagoides farinae
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code22840-0034
Application NumberBLA101834
Product Classification
M
Marketing Category
C73585
G
Generic Name
Dermatophagoides farinae
Product Specifications
Route of AdministrationINTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS
Effective DateOctober 7, 2019
FDA Product Classification
INGREDIENTS (5)
DERMATOPHAGOIDES FARINAEActive
Quantity: 10000 [AU] in 1 mL
Code: PR9U2YPF3Q
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
Dermatophagoides pteronyssinus
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code22840-0035
Application NumberBLA101835
Product Classification
M
Marketing Category
C73585
G
Generic Name
Dermatophagoides pteronyssinus
Product Specifications
Route of AdministrationINTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS
Effective DateOctober 7, 2019
FDA Product Classification
INGREDIENTS (5)
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
DERMATOPHAGOIDES PTERONYSSINUSActive
Quantity: 5000 [AU] in 1 mL
Code: 57L1Z5378K
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
Dermatophagoides farinae
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code22840-0038
Application NumberBLA101834
Product Classification
M
Marketing Category
C73585
G
Generic Name
Dermatophagoides farinae
Product Specifications
Route of AdministrationINTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS
Effective DateOctober 7, 2019
FDA Product Classification
INGREDIENTS (5)
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
DERMATOPHAGOIDES FARINAEActive
Quantity: 30000 [AU] in 1 mL
Code: PR9U2YPF3Q
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
Dermatophagoides farinae and Dermatophagoides pteronyssinus
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code22840-0037
Application NumberBLA101834
Product Classification
M
Marketing Category
C73585
G
Generic Name
Dermatophagoides farinae and Dermatophagoides pteronyssinus
Product Specifications
Route of AdministrationINTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS
Effective DateOctober 7, 2019
FDA Product Classification
INGREDIENTS (6)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
DERMATOPHAGOIDES FARINAEActive
Quantity: 5000 [AU] in 1 mL
Code: PR9U2YPF3Q
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
DERMATOPHAGOIDES PTERONYSSINUSActive
Quantity: 5000 [AU] in 1 mL
Code: 57L1Z5378K
Classification: ACTIB
Dermatophagoides farinae
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code22840-0033
Application NumberBLA101834
Product Classification
M
Marketing Category
C73585
G
Generic Name
Dermatophagoides farinae
Product Specifications
Route of AdministrationINTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS
Effective DateOctober 7, 2019
FDA Product Classification
INGREDIENTS (5)
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
DERMATOPHAGOIDES FARINAEActive
Quantity: 5000 [AU] in 1 mL
Code: PR9U2YPF3Q
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
Dermatophagoides pteronyssinus
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code22840-0039
Application NumberBLA101835
Product Classification
M
Marketing Category
C73585
G
Generic Name
Dermatophagoides pteronyssinus
Product Specifications
Route of AdministrationSUBCUTANEOUS, PERCUTANEOUS, INTRADERMAL
Effective DateOctober 7, 2019
FDA Product Classification
INGREDIENTS (5)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
DERMATOPHAGOIDES PTERONYSSINUSActive
Quantity: 30000 [AU] in 1 mL
Code: 57L1Z5378K
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
Dermatophagoides farinae and Dermatophagoides pteronyssinus
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code22840-0040
Application NumberBLA101834
Product Classification
M
Marketing Category
C73585
G
Generic Name
Dermatophagoides farinae and Dermatophagoides pteronyssinus
Product Specifications
Route of AdministrationPERCUTANEOUS, INTRADERMAL, SUBCUTANEOUS
Effective DateOctober 7, 2019
FDA Product Classification
INGREDIENTS (6)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
DERMATOPHAGOIDES FARINAEActive
Quantity: 15000 [AU] in 1 mL
Code: PR9U2YPF3Q
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
DERMATOPHAGOIDES PTERONYSSINUSActive
Quantity: 15000 [AU] in 1 mL
Code: 57L1Z5378K
Classification: ACTIB