Food - Plant Source, Tomato Nicotiana spp.

Product NDC: 65044-3657
11-digit product format: 650443657
Labeler code: 65044
Product ID: 65044-3657_7aa227ef-6590-446b-af8f-bac308d1f226
Type: NON-STANDARDIZED ALLERGENIC
Nonproprietary name: Tomato Nicotiana spp.
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: TOMATO
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],Vegetable Proteins [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65044-3657-1	2021-01-29	C162847	48780-1	ba0f9c33-4042-a910-e053-dadaa90a0b85	INSTRUCTIONS ALLERGENIC EXTRACTS FOR SCRATCH, PRICK OR PUNCTURE TESTING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65044-3657-1	Food - Plant Source, Tomato Nicotiana spp.	5 mL in 1 VIAL	INJECTION, SOLUTION	5		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65044-3657	FOOD - PLANT SOURCE, HAZELNUT FILBERT CORYLUS SPP. (HAZELNUT FILBERT CORYLUS SPP.) INJECTION, SOLUTION FOOD - PLANT SOURCE, MELON, CANTALOUPE CUCUMIS MELO (CANTALOUPE CUCUMIS MELO) INJECTION, SOLUTION FOOD - PLANT SOURCE, ORANGE CITRUS SINENSIS (ORANGE CITRUS SINENSIS) INJECTION, SOLUTION FOOD - PLANT SOURCE, PEA, GREEN OR ENGLISH PISUM SATIVUM (PEA, GREEN OR ENGLISH PISUM SATIVUM) INJECTION, SOLUTION FOOD - PLANT SOURCE, PEACH PRUNUS PERSICA (PEACH PRUNUS PERSICA) INJECTION, SOLUTION FOOD - PLANT SOURCE, PEANUT ARACHIS HYPOGAEA (PEANUT ARACHIS HYPOGAEA) INJECTION, SOLUTION FOOD - PLANT SOURCE, PECAN CARYA ILLINOENSIS (PECAN CARYA ILLINOENSIS) INJECTION, SOLUTION FOOD - PLANT SOURCE, POTATO, WHITE SOLANUM TUBEROSUM (POTATO, WHITE SOLANUM TUBEROSUM) INJECTION, SOLUTION FOOD - PLANT SOURCE, RICE, WHOLE GRAIN (RICE, WHOLE GRAIN) INJECTION, SOLUTION FOOD - PLANT SOURCE, RYE GRAIN (RYE GRAIN) INJECTION, SOLUTION FOOD - PLANT SOURCE, SOYBEAN GLYCINE SOJA (SOYBEAN GLYCINE SOJA) INJECTION, SOLUTION FOOD - PLANT SOURC	4	Legacy NDC, 1 package rows	20191122_768c463e-0c57-499e-8502-46dc9915808b.zip

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
Z4KHF2C175	TOMATO	TOMATO

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
900095	black walnut pollen extract 100 MG/ML Injectable Solution	PSN	768c463e-0c57-499e-8502-46dc9915808b	4
892520	cantaloupe allergenic extract 100 MG/ML Injectable Solution	PSN	768c463e-0c57-499e-8502-46dc9915808b	4
899958	hazelnut pollen extract 100 MG/ML Injectable Solution	PSN	768c463e-0c57-499e-8502-46dc9915808b	4
892568	orange allergenic extract 100 MG/ML Injectable Solution	PSN	768c463e-0c57-499e-8502-46dc9915808b	4
892572	pea allergenic extract 100 MG/ML Injectable Solution	PSN	768c463e-0c57-499e-8502-46dc9915808b	4
892578	peach allergenic extract 100 MG/ML Injectable Solution	PSN	768c463e-0c57-499e-8502-46dc9915808b	4
891663	peanut allergenic extract 100 MG/ML Injectable Solution	PSN	768c463e-0c57-499e-8502-46dc9915808b	4
892335	pecan allergenic extract 100 MG/ML Injectable Solution	PSN	768c463e-0c57-499e-8502-46dc9915808b	4
892635	potato allergenic extract 100 MG/ML Injectable Solution	PSN	768c463e-0c57-499e-8502-46dc9915808b	4
892664	rice (whole grain) allergenic extract 100 MG/ML Injectable Solution	PSN	768c463e-0c57-499e-8502-46dc9915808b	4
892641	rye allergenic extract 100 MG/ML Injectable Solution	PSN	768c463e-0c57-499e-8502-46dc9915808b	4
891675	soybean allergenic extract 100 MG/ML Injectable Solution	PSN	768c463e-0c57-499e-8502-46dc9915808b	4
892487	strawberry allergenic extract 50 MG/ML Injectable Solution	PSN	768c463e-0c57-499e-8502-46dc9915808b	4
891681	string bean allergenic extract 100 MG/ML Injectable Solution	PSN	768c463e-0c57-499e-8502-46dc9915808b	4
892502	tomato allergenic extract 100 MG/ML Injectable Solution	PSN	768c463e-0c57-499e-8502-46dc9915808b	4
900095	black walnut pollen extract 100 MG/ML Injectable Solution	SCD	768c463e-0c57-499e-8502-46dc9915808b	4
892520	cantaloupe allergenic extract 100 MG/ML Injectable Solution	SCD	768c463e-0c57-499e-8502-46dc9915808b	4
899958	hazelnut pollen extract 100 MG/ML Injectable Solution	SCD	768c463e-0c57-499e-8502-46dc9915808b	4
892568	orange allergenic extract 100 MG/ML Injectable Solution	SCD	768c463e-0c57-499e-8502-46dc9915808b	4
892572	pea allergenic extract 100 MG/ML Injectable Solution	SCD	768c463e-0c57-499e-8502-46dc9915808b	4
892578	peach allergenic extract 100 MG/ML Injectable Solution	SCD	768c463e-0c57-499e-8502-46dc9915808b	4
891663	peanut allergenic extract 100 MG/ML Injectable Solution	SCD	768c463e-0c57-499e-8502-46dc9915808b	4
892335	pecan allergenic extract 100 MG/ML Injectable Solution	SCD	768c463e-0c57-499e-8502-46dc9915808b	4
892635	potato allergenic extract 100 MG/ML Injectable Solution	SCD	768c463e-0c57-499e-8502-46dc9915808b	4
892664	rice (whole grain) allergenic extract 100 MG/ML Injectable Solution	SCD	768c463e-0c57-499e-8502-46dc9915808b	4
892641	rye allergenic extract 100 MG/ML Injectable Solution	SCD	768c463e-0c57-499e-8502-46dc9915808b	4
891675	soybean allergenic extract 100 MG/ML Injectable Solution	SCD	768c463e-0c57-499e-8502-46dc9915808b	4
892487	strawberry allergenic extract 50 MG/ML Injectable Solution	SCD	768c463e-0c57-499e-8502-46dc9915808b	4
891681	string bean allergenic extract 100 MG/ML Injectable Solution	SCD	768c463e-0c57-499e-8502-46dc9915808b	4
892502	tomato allergenic extract 100 MG/ML Injectable Solution	SCD	768c463e-0c57-499e-8502-46dc9915808b	4
892664	brown rice allergenic extract 100 MG/ML Injectable Solution	SY	768c463e-0c57-499e-8502-46dc9915808b	4
892520	cantaloupe allergenic extract 0.1 GM/ML Injectable Solution	SY	768c463e-0c57-499e-8502-46dc9915808b	4
899958	Corylus americana pollen extract 0.1 GM/ML Injectable Solution	SY	768c463e-0c57-499e-8502-46dc9915808b	4
899958	Corylus americana pollen extract 100 MG/ML Injectable Solution	SY	768c463e-0c57-499e-8502-46dc9915808b	4
891681	green bean allergenic extract 0.1 GM/ML Injectable Solution	SY	768c463e-0c57-499e-8502-46dc9915808b	4
900095	Juglans nigra pollen extract 0.1 GM/ML Injectable Solution	SY	768c463e-0c57-499e-8502-46dc9915808b	4
900095	Juglans nigra pollen extract 100 MG/ML Injectable Solution	SY	768c463e-0c57-499e-8502-46dc9915808b	4
892568	orange allergenic extract 0.1 GM/ML Injectable Solution	SY	768c463e-0c57-499e-8502-46dc9915808b	4
892572	pea allergenic extract 0.1 GM/ML Injectable Solution	SY	768c463e-0c57-499e-8502-46dc9915808b	4
891663	peanut allergenic extract 0.1 GM/ML Injectable Solution	SY	768c463e-0c57-499e-8502-46dc9915808b	4
892335	pecan allergenic extract 0.1 GM/ML Injectable Solution	SY	768c463e-0c57-499e-8502-46dc9915808b	4
892578	Prunus (subgenus Amygdalus) persica allergenic extract 0.1 GM/ML Injectable Solution	SY	768c463e-0c57-499e-8502-46dc9915808b	4
892578	Prunus (subgenus Amygdalus) persica allergenic extract 100 MG/ML Injectable Solution	SY	768c463e-0c57-499e-8502-46dc9915808b	4
892664	rice (whole grain) allergenic extract 0.1 GM/ML Injectable Solution	SY	768c463e-0c57-499e-8502-46dc9915808b	4
892641	rye allergenic extract 0.1 GM/ML Injectable Solution	SY	768c463e-0c57-499e-8502-46dc9915808b	4
892635	Solanum tuberosum allergenic extract 0.1 GM/ML Injectable Solution	SY	768c463e-0c57-499e-8502-46dc9915808b	4
892635	Solanum tuberosum allergenic extract 100 MG/ML Injectable Solution	SY	768c463e-0c57-499e-8502-46dc9915808b	4
891675	soybean allergenic extract 0.1 GM/ML Injectable Solution	SY	768c463e-0c57-499e-8502-46dc9915808b	4
892487	strawberry allergenic extract 0.05 GM/ML Injectable Solution	SY	768c463e-0c57-499e-8502-46dc9915808b	4
892502	tomato allergenic extract 0.1 GM/ML Injectable Solution	SY	768c463e-0c57-499e-8502-46dc9915808b	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
65044-3657-1	65044365701	5 mL in 1 VIAL	5 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
INSTRUCTIONS ALLERGENIC EXTRACTS FOR SCRATCH, PRICK OR PUNCTURE TESTING	Jubilant HollisterStier LLC	2018-03-13	NON-STANDARDIZED ALLERGENIC LABEL	4

Food - Plant Source, Tomato Nicotiana spp.

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#