Carp
Allergenic Extract
Approved
Approval ID
eeb27826-8811-4630-8ff6-e4926db34f38
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 10, 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.
Smelt
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1263
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Smelt
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (6)
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SMELTActive
Quantity: 0.05 g in 1 mL
Code: 9VVF5SCM9I
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
Pike
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1239
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Pike
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (6)
NORTHERN PIKEActive
Quantity: 0.05 g in 1 mL
Code: 5JKY494U4L
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
Sardine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1251
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Sardine
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (6)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
EUROPEAN PILCHARDActive
Quantity: 0.05 g in 1 mL
Code: 76780GX08D
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Mackerel
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1231
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Mackerel
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (6)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
MACKERELActive
Quantity: 0.05 g in 1 mL
Code: CYO6K3VM7F
Classification: ACTIB
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Scallop
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1255
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Scallop
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (6)
SCALLOPActive
Quantity: 0.05 g in 1 mL
Code: D380C73WOU
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
White Fish
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1279
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
White Fish
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (6)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WHITE FISHActive
Quantity: 0.05 g in 1 mL
Code: IA4C8ND0DT
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Oyster
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1235
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Oyster
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (6)
OYSTERActive
Quantity: 0.05 g in 1 mL
Code: S614XWR17V
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
Trout
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1271
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Trout
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (6)
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
TROUTActive
Quantity: 0.05 g in 1 mL
Code: 7TI7U5PF2U
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Salmon
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1247
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Salmon
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (6)
ATLANTIC SALMONActive
Quantity: 0.05 g in 1 mL
Code: 7062I37LB3
Classification: ACTIB
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Shrimp
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1259
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Shrimp
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 10, 2009
FDA Product Classification
INGREDIENTS (6)
SHRIMPActive
Quantity: 0.05 g in 1 mL
Code: 1891LE191T
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Drug Labeling Information
HOW SUPPLIED SECTION
LOINC: 34069-5Updated: 12/10/2009
HOW SUPPLIED
Allergenic extracts are supplied with units listed as: Weight/volume (W/V), Protein Nitrogen Units (PNU/ml), Allergy Units (AU/ml) or Bioequivalent Allergy Units (BAU/ml).
Sizes:
Diagnostic Scratch: 5 ml dropper application vials
Diagnostic Intradermal: 5 ml or 10 ml vials.
Therapeutic Allergens: 5 ml, 10 ml, 50 ml multiple dose vials.