FDA.reportPublic FDA data

Molds, Rusts and Smuts, Botrytis cinerea

Product NDC
65044-5048
11-digit product format
650445048
Labeler code
65044
Product ID
65044-5048_b92e5087-bcde-4bcc-a899-2e078a039d30
Type
NON-STANDARDIZED ALLERGENIC
Nonproprietary name
Botrytis cinerea
Dosage form
INJECTION, SOLUTION
Route
PERCUTANEOUS; SUBCUTANEOUS
Labeler
Jubilant HollisterStier LLC
Application
BLA103888
Marketing category
BLA
Marketing start
1941-04-19
Substance
BOTRYTIS CINEREA
Active strength
.1 g/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Molds, Rusts and Smuts, Botrytis cinerea
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BOTRYTIS CINEREA.1 g/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65044-5048-2Molds, Rusts and Smuts, Botrytis cinerea10 mL in 1 VIALINJECTION, SOLUTION1018
65044-5048-3Molds, Rusts and Smuts, Botrytis cinerea30 mL in 1 VIALINJECTION, SOLUTION3018
65044-5048-4Molds, Rusts and Smuts, Botrytis cinerea50 mL in 1 VIALINJECTION, SOLUTION5018
65044-5048-2Molds, Rusts and Smuts, Botrytis cinerea10 mL in 1 VIALINJECTION, SOLUTION102
65044-5048-3Molds, Rusts and Smuts, Botrytis cinerea30 mL in 1 VIALINJECTION, SOLUTION302
65044-5048-4Molds, Rusts and Smuts, Botrytis cinerea50 mL in 1 VIALINJECTION, SOLUTION502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65044-5048ANIMAL ALLERGENS, AP CATTLE HAIR AND DANDER (CATTLE HAIR AND DANDER) INJECTION, SOLUTION ANIMAL ALLERGENS, AP DOG HAIR AND DANDER CANIS SPP (ANIMAL ALLERGENS, DOG DANDER CANIS SPP) INJECTION, SOLUTION ANIMAL ALLERGENS, DOG HAIR AND DANDER CANIS SPP. (DOG HAIR CANIS SPP.) INJECTION, SOLUTION ANIMAL ALLERGENS, AP HORSE HAIR AND DANDER (AP HORSE HAIR .......CTION, SOLUTION POLLENS - TREES, MULBERRY MIX (MULBERRY MIX) INJECTION, SOLUTION POLLENS - TREES, OAK MIX (OAK MIX) INJECTION, SOLUTION POLLENS - TREES, OAK, RED QUERCUS RUBRA (OAK, RED QUERCUS RUBRA) INJECTION, SOLUTION ANIMAL ALLERGENS, UF DOG HAIR-DANDER CANIS SPP (ANIMAL ALLERGENS, DOG DANDER CANIS SPP) INJECTION, SOLUTION [JUBILANT HOLLISTERSTIER LLC]17Current NDC, Legacy NDC, 3 package rows20241115_97e5c6c0-7101-49b7-8ac4-9dfc60f60cc5.zip
65044-5048INSECTS WHOLE BODY, FIRE ANT MIX INJECTION, SOLUTION MOLDS - ALTERNARIA/HORMODENDRUM MIX INJECTION, SOLUTION MOLDS - MOLD MIX 10 INJECTION, SOLUTION MOLDS - MOLD MIX 4 INJECTION, SOLUTION MOLDS - TRICHOPHYTON MIX INJECTION, SOLUTION MOLDS, PENICILLIUM MIX INJECTION, SOLUTION MOLDS, RUSTS AND SMUTS, ALTERNARIA TENUIS (ALTERNARIA TENUIS) INJECTION, SOLUTION MOLDS, RUSTS AND SMUTS, ASPERGILLUS FUMIGATUS (ASPERGILLUS FUMIGATUS) INJECTION, SOLUTION MOLDS, RUSTS AND SMUTS, ASPERGILLUS NIGER (ASPERGILLUS NIGER) INJECTION, SOLUTION MOLDS, RUSTS AND SMUTS, BOTRYTIS CINEREA (BOTRYTIS CINEREA) INJECTION, SOLUTION MOLDS, RUSTS AND SMUTS, CANDIDA ALBICANS (CANDIDA ALBICANS) INJECTION, SOLUTION MOLDS, RUSTS AND SMUTS, CEPHALOSPORIUM ACREMONIUM (CEPHALOSPORIUM ACREMONIUM) INJECTION, SOLUTION MOLDS, RUSTS AND SMUTS, CURVULARIA SPICIFERA (CURVULARIA SPICIFERA) INJECTION, SOLUTION MOLDS, RUSTS AND SMUTS, EPICOCCUM NIGRUM (EPICOCCUM NIGRUM) INJECTION, SOLUTION [JUBILANT HOLLISTERSTIER LLC]2Current NDC, Legacy NDC, 3 package rows20171027_6377f3f6-7c85-4387-b3e0-acd1ea1aca8d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905075Acremonium strictum allergenic extract 100 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
892510almond allergenic extract 100 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
995771Alternaria alternata allergenic extract 100 MG/ML / Cladosporium cladosporioides allergenic extract 100 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
901848Alternaria alternata allergenic extract 100 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
995757American basswood pollen extract 50 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
1091110American cockroach allergenic extract 100 MG/ML / German cockroach allergenic extract 100 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
966777American cockroach allergenic extract 100 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
1193014American cockroach allergenic extract 20,000 UNT/ML / German cockroach allergenic extract 20,000 UNT/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
991865American cockroach allergenic extract 5000 UNT/ML / German cockroach allergenic extract 5000 UNT/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
883416American elm pollen extract 100 MG/mL Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
889556American elm pollen extract 40000 UNT/mL Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
852057American elm pollen extract 50 MG/mL Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
891774apple allergenic extract 100 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
852817Arizona cypress pollen extract 50 MG/mL Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
852060Aspergillus fumigatus extract 100 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
995697Aspergillus niger var. niger extract 100 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
898132bahia grass pollen extract 100 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
852676bahia grass pollen extract 50 MG/mL Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
995750bald cypress pollen extract 20 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
891833banana allergenic extract 100 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
852422beech pollen extract 50 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
892602beef allergenic extract 100 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
1091115black imported fire ant allergenic extract 100 MG/ML / red imported fire ant allergenic extract 100 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
900095black walnut pollen extract 100 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
852572black walnut pollen extract 50 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
852165black willow pollen extract 50 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
1115265bluegum eucalyptus pollen extract 50 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
852192Botrytis cinerea allergenic extract 100 MG/mL Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
852236bottlebrush pollen extract 50 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
899504box elder maple pollen extract 50 MG/ML / hard maple pollen extract 50 MG/ML / red maple pollen extract 50 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
891657brazil nut allergenic extract 100 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
967761bread mold fungus extract 100 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
903916broad leaved paperbark pollen extract 50 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
897991burning bush pollen extract 100 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
852596burning bush pollen extract 50 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
1242958burweed marshelder pollen extract 50 MG/ML / poverty weed pollen extract 50 MG/ML / rough marshelder pollen extract 50 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
995746Canada goldenrod pollen extract 50 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
991857Candida albicans allergenic extract 1 MG/mL Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
967032Candida albicans extract 100 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
892520cantaloupe allergenic extract 100 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
895720careless weed pollen extract 100 MG/ML / redroot pigweed pollen extract 100 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
895716careless weed pollen extract 50 MG/ML / redroot pigweed pollen extract 50 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
851929careless weed pollen extract 50 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
892371carrot allergenic extract 100 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
892607casein (cow milk) allergenic extract 100 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
892529cashew nut allergenic extract 100 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
892375celery allergenic extract 100 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
892656chicken allergenic extract 100 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
852847Chinese elm pollen extract 50 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
967053Cladosporium cladosporioides extract 100 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
892542clam allergenic extract 100 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
995702Cochliobolus spicifer allergenic extract 100 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
892546codfish allergenic extract 100 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
892550corn allergenic extract 100 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
852018corn pollen extract 50 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
892668cow milk allergenic extract 50 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
892613crab allergenic extract 100 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
852117cultivated oat pollen extract 50 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
995706Dendryphiella vinosa allergenic extract 100 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
995560dog hair extract 5 MG/mL / dog skin extract 5 MG/mL Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
995561dog hair extract 50 MG/mL / dog skin extract 50 MG/mL Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
897506dogfennel pollen extract 50 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
995555domestic cow hair extract 10 MG/mL / domestic cow skin extract 10 MG/mL Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
898422eastern cottonwood pollen extract 20000 UNT/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
852366eastern cottonwood pollen extract 50 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
852749eastern sycamore pollen extract 50 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
892619egg white (chicken) allergenic extract 50 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
892623egg yolk (chicken) allergenic extract 50 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
898329English plantain pollen extract 100 MG/mL Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
898337English plantain pollen extract 20,000 UNT/mL Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
898339English plantain pollen extract 40,000 UNT/mL Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
852745English plantain pollen extract 50 MG/mL Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
852469Epicoccum nigrum extract 100 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
995710Epidermophyton floccosum allergenic extract 100 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
898024European olive pollen extract 100 MG/mL Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
852656European olive pollen extract 50 MG/mL Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
995725Fusarium oxysporum vasinfectum allergenic extract 100 MG/mL Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
966784German cockroach allergenic extract 100 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
896179giant ragweed pollen extract 100 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518
852001giant ragweed pollen extract 50 MG/ML Injectable SolutionPSN97e5c6c0-7101-49b7-8ac4-9dfc60f60cc518

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65044-5048-26504450480210 mL in 1 VIAL (65044-5048-2) 10 ml1941-04-190000-00-00NoNoCurrent
65044-5048-36504450480330 mL in 1 VIAL (65044-5048-3) 30 ml1941-04-190000-00-00NoNoCurrent
65044-5048-46504450480450 mL in 1 VIAL (65044-5048-4) 50 ml1941-04-190000-00-00NoNoCurrent