Bahia Grass
Allergenic Extract
Approved
Approval ID
97c8bed1-efbd-4af1-b242-85f80edeee5b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 4, 2009
Manufacturers
FDA
Nelco Laboratories, Inc.
DUNS: 054980867
Products 10
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
West Wheat Grass
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2423
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
West Wheat Grass
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 4, 2009
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PASCOPYRUM SMITHII POLLENActive
Quantity: 40000 [PNU] in 1 mL
Code: 6AU0ZD8T1O
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
Cultivated Wheat
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2415
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Cultivated Wheat
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 4, 2009
FDA Product Classification
INGREDIENTS (5)
TRITICUM AESTIVUM POLLENActive
Quantity: 40000 [PNU] in 1 mL
Code: F1KAH8374D
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Cultivated Rye
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2369
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Cultivated Rye
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 4, 2009
FDA Product Classification
INGREDIENTS (5)
SECALE CEREALE POLLENActive
Quantity: 40000 [PNU] in 1 mL
Code: I6KAZ8AO1O
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Giant Wild Rye
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2377
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Giant Wild Rye
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 4, 2009
FDA Product Classification
INGREDIENTS (5)
LEYMUS CONDENSATUS POLLENActive
Quantity: 40000 [PNU] in 1 mL
Code: 257GC6QO0Q
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
Velvet Grass
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2407
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Velvet Grass
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 4, 2009
FDA Product Classification
INGREDIENTS (5)
DISTICHLIS SPICATA POLLENActive
Quantity: 40000 [PNU] in 1 mL
Code: GOA51670YV
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Canary Grass
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2299
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Canary Grass
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 4, 2009
FDA Product Classification
INGREDIENTS (5)
PHALARIS ARUNDINACEA POLLENActive
Quantity: 40000 [PNU] in 1 mL
Code: FAY1Y90VJ9
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
Smooth Brome
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2441
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Smooth Brome
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 4, 2009
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
BROMUS INERMIS POLLENActive
Quantity: 40000 [PNU] in 1 mL
Code: 766QT72BK6
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Cultivated Oat
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2341
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Cultivated Oat
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 4, 2009
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
AVENA SATIVA POLLENActive
Quantity: 40000 [PNU] in 1 mL
Code: A7IKY24TR7
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
Salt Grass
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2395
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Salt Grass
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 4, 2009
FDA Product Classification
INGREDIENTS (5)
DISTICHLIS SPICATA POLLENActive
Quantity: 40000 [PNU] in 1 mL
Code: GOA51670YV
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
Soft Cheat Brome
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-2433
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Soft Cheat Brome
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 4, 2009
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
BROMUS INERMIS POLLENActive
Quantity: 40000 [PNU] in 1 mL
Code: 766QT72BK6
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT