Food - Plant Source, Brazil Nut Bertholletia excelsa

Product NDC
65044-3108
11-digit product format
650443108
Labeler code
65044
Product ID
65044-3108_a75e0709-e1c2-49ca-8c13-7e21d455d883
Type
NON-STANDARDIZED ALLERGENIC
Nonproprietary name
Brazil Nut Bertholletia excelsa
Dosage form
INJECTION, SOLUTION
Route
PERCUTANEOUS
Labeler
Jubilant HollisterStier LLC
Application
BLA103888
Marketing category
BLA
Marketing start
1941-04-19
Marketing end
0000-00-00
Substance
BRAZIL NUT
Active strength
0 g/mL
Pharmacologic classes
Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Nut Proteins [EXT]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65044-3108-12020-01-31C16284748780-19d75b9d0-ab3d-f424-e053-dadaa90a57ceINSTRUCTIONS ALLERGENIC EXTRACTS FOR SCRATCH, PRICK OR PUNCTURE TESTING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65044-3108-1Food - Plant Source, Brazil Nut Bertholletia excelsa5 mL in 1 VIALINJECTION, SOLUTION53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65044-3108FOOD - FISH AND SHELLFISH, CLAM (CLAM) INJECTION, SOLUTION FOOD - FISH AND SHELLFISH, CODFISH GADUS CALLARIAS (CODFISH GADUS CALLARIAS) INJECTION, SOLUTION FOOD - FISH AND SHELLFISH, CRAB XIPHOSURUS SOWERBYI (CRAB XIPHOSURUS SOWERBYI) INJECTION, SOLUTION FOOD - FISH AND SHELLFISH, LOBSTER HOMARUS AMERICANUS (LOBSTER HOMARUS AMERICANUS) INJECTION, SOLUTION FOOD - FISH AND SHELLFISH, SALMON SALMO SALAR (SALMON SALMO SALAR) INJECTION, SOLUTION FOOD - FISH AND SHELLFISH, SHRIMP CRAGO SP. (SHRIMP CRAGO SP.) INJECTION, SOLUTION FOOD - FISH AND SHELLFISH, TUNA THUNNUS SP. (TUNA THUNNUS SP.) INJECTION, SOLUTION FOOD - PLANT SOURCE, ALMOND PRUNUS AMYGDALUS (ALMOND PRUNUS AMYGDALUS) INJECTION, SOLUTION FOOD - PLANT SOURCE, APPLE MALUS SP. (APPLE MALUS SP.) INJECTION, SOLUTION FOOD - PLANT SOURCE, BANANA MUSA SAPIENTUM (BANANA MUSA SAPIENTUM) INJECTION, SOLUTION FOOD - PLANT SOURCE, BRAZIL NUT BERTHOLLETIA EXCELSA (BRAZIL NUT BERTHOLLETIA EXCELSA) INJECTION, SOLUTION FOOD - PLANT SOURCE, CARROT DAUCUS CAROTA (CARROT DAU3Legacy NDC, 1 package rows20180620_23151965-3ccd-49e0-a072-effc6c2efdac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892510almond allergenic extract 100 MG/ML Injectable SolutionPSN23151965-3ccd-49e0-a072-effc6c2efdac3
891774apple allergenic extract 100 MG/ML Injectable SolutionPSN23151965-3ccd-49e0-a072-effc6c2efdac3
891833banana allergenic extract 100 MG/ML Injectable SolutionPSN23151965-3ccd-49e0-a072-effc6c2efdac3
891657brazil nut allergenic extract 100 MG/ML Injectable SolutionPSN23151965-3ccd-49e0-a072-effc6c2efdac3
892371carrot allergenic extract 100 MG/ML Injectable SolutionPSN23151965-3ccd-49e0-a072-effc6c2efdac3
892529cashew nut allergenic extract 100 MG/ML Injectable SolutionPSN23151965-3ccd-49e0-a072-effc6c2efdac3
892375celery allergenic extract 100 MG/ML Injectable SolutionPSN23151965-3ccd-49e0-a072-effc6c2efdac3
892542clam allergenic extract 100 MG/ML Injectable SolutionPSN23151965-3ccd-49e0-a072-effc6c2efdac3
892546codfish allergenic extract 100 MG/ML Injectable SolutionPSN23151965-3ccd-49e0-a072-effc6c2efdac3
892550corn allergenic extract 100 MG/ML Injectable SolutionPSN23151965-3ccd-49e0-a072-effc6c2efdac3
892613crab allergenic extract 100 MG/ML Injectable SolutionPSN23151965-3ccd-49e0-a072-effc6c2efdac3
892564lobster allergenic extract 100 MG/ML Injectable SolutionPSN23151965-3ccd-49e0-a072-effc6c2efdac3
892587salmon allergenic extract 100 MG/ML Injectable SolutionPSN23151965-3ccd-49e0-a072-effc6c2efdac3
892595shrimp allergenic extract 100 MG/ML Injectable SolutionPSN23151965-3ccd-49e0-a072-effc6c2efdac3
892506tuna allergenic extract 100 MG/ML Injectable SolutionPSN23151965-3ccd-49e0-a072-effc6c2efdac3
892510almond allergenic extract 100 MG/ML Injectable SolutionSCD23151965-3ccd-49e0-a072-effc6c2efdac3
891774apple allergenic extract 100 MG/ML Injectable SolutionSCD23151965-3ccd-49e0-a072-effc6c2efdac3
891833banana allergenic extract 100 MG/ML Injectable SolutionSCD23151965-3ccd-49e0-a072-effc6c2efdac3
891657brazil nut allergenic extract 100 MG/ML Injectable SolutionSCD23151965-3ccd-49e0-a072-effc6c2efdac3
892371carrot allergenic extract 100 MG/ML Injectable SolutionSCD23151965-3ccd-49e0-a072-effc6c2efdac3
892529cashew nut allergenic extract 100 MG/ML Injectable SolutionSCD23151965-3ccd-49e0-a072-effc6c2efdac3
892375celery allergenic extract 100 MG/ML Injectable SolutionSCD23151965-3ccd-49e0-a072-effc6c2efdac3
892542clam allergenic extract 100 MG/ML Injectable SolutionSCD23151965-3ccd-49e0-a072-effc6c2efdac3
892546codfish allergenic extract 100 MG/ML Injectable SolutionSCD23151965-3ccd-49e0-a072-effc6c2efdac3
892550corn allergenic extract 100 MG/ML Injectable SolutionSCD23151965-3ccd-49e0-a072-effc6c2efdac3
892613crab allergenic extract 100 MG/ML Injectable SolutionSCD23151965-3ccd-49e0-a072-effc6c2efdac3
892564lobster allergenic extract 100 MG/ML Injectable SolutionSCD23151965-3ccd-49e0-a072-effc6c2efdac3
892587salmon allergenic extract 100 MG/ML Injectable SolutionSCD23151965-3ccd-49e0-a072-effc6c2efdac3
892595shrimp allergenic extract 100 MG/ML Injectable SolutionSCD23151965-3ccd-49e0-a072-effc6c2efdac3
892506tuna allergenic extract 100 MG/ML Injectable SolutionSCD23151965-3ccd-49e0-a072-effc6c2efdac3
892510almond allergenic extract 0.1 GM/ML Injectable SolutionSY23151965-3ccd-49e0-a072-effc6c2efdac3
892529Anacardium occidentale allergenic extract 0.1 GM/ML Injectable SolutionSY23151965-3ccd-49e0-a072-effc6c2efdac3
891774apple allergenic extract 0.1 GM/ML Injectable SolutionSY23151965-3ccd-49e0-a072-effc6c2efdac3
891833banana allergenic extract 0.1 GM/ML Injectable SolutionSY23151965-3ccd-49e0-a072-effc6c2efdac3
891657brazil nut allergenic extract 0.1 GM/ML Injectable SolutionSY23151965-3ccd-49e0-a072-effc6c2efdac3
892371carrot allergenic extract 0.1 GM/ML Injectable SolutionSY23151965-3ccd-49e0-a072-effc6c2efdac3
892529cashew nut allergenic extract 0.1 GM/ML Injectable SolutionSY23151965-3ccd-49e0-a072-effc6c2efdac3
892375celery allergenic extract 0.1 GM/ML Injectable SolutionSY23151965-3ccd-49e0-a072-effc6c2efdac3
892546codfish allergenic extract 0.1 GM/ML Injectable SolutionSY23151965-3ccd-49e0-a072-effc6c2efdac3
892550corn allergenic extract 0.1 GM/ML Injectable SolutionSY23151965-3ccd-49e0-a072-effc6c2efdac3
892613crab allergenic extract 0.1 GM/ML Injectable SolutionSY23151965-3ccd-49e0-a072-effc6c2efdac3
892564lobster allergenic extract 0.1 GM/ML Injectable SolutionSY23151965-3ccd-49e0-a072-effc6c2efdac3
892542quahog allergenic extract 0.1 GM/ML Injectable SolutionSY23151965-3ccd-49e0-a072-effc6c2efdac3
892587salmon allergenic extract 0.1 GM/ML Injectable SolutionSY23151965-3ccd-49e0-a072-effc6c2efdac3
892595shrimp allergenic extract 0.1 GM/ML Injectable SolutionSY23151965-3ccd-49e0-a072-effc6c2efdac3
892506tuna allergenic extract 0.1 GM/ML Injectable SolutionSY23151965-3ccd-49e0-a072-effc6c2efdac3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
65044-3108-1650443108015 mL in 1 VIAL5 mlHistorical