FDA.reportPublic FDA data

SACCHAROMYCES CEREVISIAE

Product NDC
0268-0969
11-digit product format
002680969
Labeler code
0268
Product ID
0268-0969_152accc2-8563-4b11-9c7c-f61b002b30f8
Type
NON-STANDARDIZED ALLERGENIC
Nonproprietary name
SACCHAROMYCES CEREVISIAE
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
ALK-Abello, Inc.
Application
BLA103753
Marketing category
BLA
Marketing start
1965-01-01
Marketing end
0000-00-00
Substance
SACCHAROMYCES CEREVISIAE
Active strength
10000 [PNU]/mL
Pharmacologic classes
Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Fungal Proteins [CS],Non-Standardized Fungal Allergenic Extract [EPC],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Dietary Proteins [CS],Allergens [CS],Fungal Proteins [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0268-0969-10SACCHAROMYCES CEREVISIAE10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION1013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0268-0969SOLIDAGO CANADENSIS POLLEN (GOLDENROD) INJECTION, SOLUTION JUNIPERUS CALIFORNICA POLLEN (JUNIPER WESTERN) INJECTION, SOLUTION CHENOPODIUM ALBUM POLLEN (LAMBS QUARTERS) INJECTION, SOLUTION CHENOPODIUM AMBROSIOIDES POLLEN (MEXICAN TEA) INJECTION, SOLUTION QUERCUS AGRIFOLIA POLLEN (OAK CALIFORNIA LIVE COAST) INJECTION ......./STRONG> JUGLANS REGIA POLLEN (WALNUT ENGLISH POLLEN) INJECTION, SOLUTION AMARANTHUS TUBERCULATUS POLLEN (WATER HEMP) INJECTION, SOLUTION TRITICUM AESTIVUM POLLEN (WHEAT POLLEN) INJECTION, SOLUTION SALIX NIGRA POLLEN (WILLOW BLACK) INJECTION, SOLUTION ARTEMISIA ANNUA POLLEN (WORMWOOD COMMON ANNUAL) INJECTION, SOLUTION [ALK-ABELLO, INC.]13Legacy NDC, 1 package rows20230603_1e72cad7-cd64-4c32-bf05-76a32b99e874.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
851735Acacia pollen extract 50 MG/mL Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
905077Acremonium strictum allergenic extract 10000 UNT/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
905079Acremonium strictum allergenic extract 20000 UNT/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
905081Acremonium strictum allergenic extract 40000 UNT/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
1115827alfalfa pollen extract 1000 UNT/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
898010alfalfa pollen extract 50 MG/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
968512Alternaria alternata allergenic extract 1 MG/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
966656Alternaria alternata allergenic extract 10 MG/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
1191183Alternaria alternata allergenic extract 10 UNT/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
902638Alternaria alternata allergenic extract 10,000 UNT/mL Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
998447Alternaria alternata allergenic extract 100 UNT/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
867127Alternaria alternata allergenic extract 1000 UNT/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
966658Alternaria alternata allergenic extract 20 MG/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
1000163Alternaria alternata allergenic extract 20000 UNT/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
307874Alternaria alternata allergenic extract 40,000 UNT/mL Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
966707American cockroach allergenic extract 1 MG/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
966739American cockroach allergenic extract 10 UNT/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
966779American cockroach allergenic extract 100 UNT/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
966803American cockroach allergenic extract 1000 MG/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
905264American cockroach allergenic extract 10000 UNT/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
905267American cockroach allergenic extract 20000 UNT/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
905261American cockroach allergenic extract 50 MG/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
1232648American elm pollen extract 0.5 MG/mL Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
1232650American elm pollen extract 1 MG/mL Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
883416American elm pollen extract 100 MG/mL Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
889558American elm pollen extract 20000 UNT/mL Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
889556American elm pollen extract 40000 UNT/mL Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
1232655American elm pollen extract 5 MG/mL Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
852057American elm pollen extract 50 MG/mL Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
1044492annual bluegrass pollen extract 100 MG/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
898407annual bluegrass pollen extract 50 MG/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
968819arabic gum allergenic extract 100 MG/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
900066Arizona ash pollen extract 100 MG/mL Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
307966Arizona ash pollen extract 10000 UNT/mL Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
852499Arizona ash pollen extract 50 MG/mL Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
899964Arizona cypress pollen extract 100 MG/mL Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
852817Arizona cypress pollen extract 50 MG/mL Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
1012218aspen pollen extract 100 MG/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
852342aspen pollen extract 50 MG/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
968514Aspergillus fumigatus allergenic extract 1 MG/mL Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
968526Aspergillus fumigatus allergenic extract 10 UNT/mL Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
867153Aspergillus fumigatus allergenic extract 10,000 UNT/mL Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
968528Aspergillus fumigatus allergenic extract 100 UNT/mL Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
867151Aspergillus fumigatus allergenic extract 1000 UNT/mL Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
968520Aspergillus fumigatus allergenic extract 20 MG/mL Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
968534Aspergillus fumigatus allergenic extract 20,000 UNT/mL Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
968540Aspergillus fumigatus allergenic extract 40,000 UNT/mL Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
1006305Aspergillus niger var. niger allergenic extract 40000 UNT/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
999400Aspergillus niger var. niger extract 10,000 UNT/mL Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
999402Aspergillus niger var. niger extract 20,000 UNT/mL Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
999418Aureobasidium pullulans var. pullutans allergenic extract 10,000 UNT/mL Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
999425Aureobasidium pullulans var. pullutans allergenic extract 20,000 UNT/mL Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
1012049Aureobasidium pullulans var. pullutans allergenic extract 40,000 UNT/mL Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
899694Australian pine pollen extract 100 MG/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
899769Australian pine pollen extract 40000 UNT/mL Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
852232Australian pine pollen extract 50 MG/mL Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
1191218Australian pine pollen extract 50000 UNT/mL Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
1115965bahia grass pollen extract 1 MG/mL Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
898132bahia grass pollen extract 100 MG/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
898134bahia grass pollen extract 10000 UNT/mL Injectable SuspensionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
898136bahia grass pollen extract 20,000 UNT/mL Injectable SuspensionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
992850bahia grass pollen extract 40,000 UNT/mL Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
852676bahia grass pollen extract 50 MG/mL Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
1232629bald cypress pollen extract 1 MG/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
1044359bald cypress pollen extract 100 MG/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
1013964bald cypress pollen extract 50 MG/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
900024beech pollen extract 100 MG/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
900030beech pollen extract 20000 UNT/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
900036beech pollen extract 40000 UNT/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
852422beech pollen extract 50 MG/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
901025black locust pollen extract 50 MG/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
900095black walnut pollen extract 100 MG/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
1013889black walnut pollen extract 40000 UNT/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
852572black walnut pollen extract 50 MG/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
1232610black willow pollen extract 1 MG/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
1014328black willow pollen extract 100 MG/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
884183black willow pollen extract 10000 UNT/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
1014337black willow pollen extract 40000 UNT/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
852165black willow pollen extract 50 MG/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413
1115271bluegum eucalyptus pollen extract 100 MG/ML Injectable SolutionPSN1e72cad7-cd64-4c32-bf05-76a32b99e87413

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0268-0969-100026809691010 mL in 1 VIAL, MULTI-DOSE (0268-0969-10) 10 ml1965-01-010000-00-00NoNoCurrent