Coffee

Product NDC
49288-0100
11-digit product format
492880100
Labeler code
49288
Product ID
49288-0100_afc65820-1d95-4bc6-81a6-ef5ca82cbd81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Coffee
Dosage form
INJECTION, SOLUTION
Route
INTRADERMAL; SUBCUTANEOUS
Labeler
Antigen Laboratories, Inc.
Application
BLA102223
Marketing category
BLA
Marketing start
1974-03-23
Marketing end
0000-00-00
Substance
ARABICA COFFEE BEAN
Active strength
0 g/mL
Pharmacologic classes
Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Seed Storage Proteins [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
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e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
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08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
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810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
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ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49288-0100-1Coffee2 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION22
49288-0100-2Coffee5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION52
49288-0100-3Coffee10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION102
49288-0100-4Coffee30 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION302
49288-0100-5Coffee50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION502

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARABICA COFFEE BEANACTIVE INGREDIENT3SW678MX72FLAXSEED INJECTION, SOLUTION COFFEE INJECTION, SOLUTION COTTONSEED INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]2
COTTON SEEDACTIVE INGREDIENTDI0ZRJ0MXNFLAXSEED INJECTION, SOLUTION COFFEE INJECTION, SOLUTION COTTONSEED INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]2
FLAX SEEDACTIVE INGREDIENT4110YT348CFLAXSEED INJECTION, SOLUTION COFFEE INJECTION, SOLUTION COTTONSEED INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]2
ARABICA COFFEE BEANACTIVE MOIETY3SW678MX72FLAXSEED INJECTION, SOLUTION COFFEE INJECTION, SOLUTION COTTONSEED INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]2
COTTON SEEDACTIVE MOIETYDI0ZRJ0MXNFLAXSEED INJECTION, SOLUTION COFFEE INJECTION, SOLUTION COTTONSEED INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]2
FLAX SEEDACTIVE MOIETY4110YT348CFLAXSEED INJECTION, SOLUTION COFFEE INJECTION, SOLUTION COTTONSEED INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXFLAXSEED INJECTION, SOLUTION COFFEE INJECTION, SOLUTION COTTONSEED INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]2
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOFLAXSEED INJECTION, SOLUTION COFFEE INJECTION, SOLUTION COTTONSEED INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XFLAXSEED INJECTION, SOLUTION COFFEE INJECTION, SOLUTION COTTONSEED INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RFLAXSEED INJECTION, SOLUTION COFFEE INJECTION, SOLUTION COTTONSEED INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49288-0100FLAXSEED INJECTION, SOLUTION COFFEE INJECTION, SOLUTION COTTONSEED INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]2Legacy NDC, 5 package rows20091120_040dacaf-4ccf-425a-9b40-586176b7631d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891505arabica coffee bean allergenic extract 50 MG/ML Injectable SolutionPSN040dacaf-4ccf-425a-9b40-586176b7631d2
966958cottonseed allergenic extract 50 MG/mL Injectable SolutionPSN040dacaf-4ccf-425a-9b40-586176b7631d2
978958flaxseed allergenic extract 50 MG/ML Injectable SolutionPSN040dacaf-4ccf-425a-9b40-586176b7631d2
891505arabica coffee bean allergenic extract 50 MG/ML Injectable SolutionSCD040dacaf-4ccf-425a-9b40-586176b7631d2
966958cottonseed allergenic extract 50 MG/ML Injectable SolutionSCD040dacaf-4ccf-425a-9b40-586176b7631d2
978958flaxseed allergenic extract 50 MG/ML Injectable SolutionSCD040dacaf-4ccf-425a-9b40-586176b7631d2
891505arabica coffee bean allergenic extract 0.05 GM/ML Injectable SolutionSY040dacaf-4ccf-425a-9b40-586176b7631d2
891505arabica coffee bean extract 50 MG/ML Injectable SolutionSY040dacaf-4ccf-425a-9b40-586176b7631d2
966958cottonseed allergenic extract 0.05 GM/ML Injectable SolutionSY040dacaf-4ccf-425a-9b40-586176b7631d2
978958flaxseed allergenic extract 0.05 GM/ML Injectable SolutionSY040dacaf-4ccf-425a-9b40-586176b7631d2
978958flaxseed extract 50 MG/ML Injectable SolutionSY040dacaf-4ccf-425a-9b40-586176b7631d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
49288-0100-1492880100012 mL in 1 VIAL, MULTI-DOSE2 mlHistorical
49288-0100-2492880100025 mL in 1 VIAL, MULTI-DOSE5 mlHistorical
49288-0100-34928801000310 mL in 1 VIAL, MULTI-DOSE10 mlHistorical
49288-0100-44928801000430 mL in 1 VIAL, MULTI-DOSE30 mlHistorical
49288-0100-54928801000550 mL in 1 VIAL, MULTI-DOSE50 mlHistorical