FDA.reportPublic FDA data

Pollens - Weeds and Garden Plants, Ragweed, Mixed Ambrosia

Product NDC
65044-2316
11-digit product format
650442316
Labeler code
65044
Product ID
65044-2316_344b9384-b01d-4284-8506-00cf84d83b68
Type
STANDARDIZED ALLERGENIC
Nonproprietary name
Ragweed, Mixed Ambrosia
Dosage form
INJECTION, SOLUTION
Route
INTRADERMAL
Labeler
Jubilant HollisterStier LLC
Application
BLA103880
Marketing category
BLA
Marketing start
1977-10-18
Marketing end
0000-00-00
Substance
AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN
Active strength
500 [PNU]/mL; [PNU]/mL
Pharmacologic classes
Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct65044-2316DDiscontinued by firm2026-07-31
excluded packagepackage65044-231665044-2316-5DDiscontinued by firm2026-07-31

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
65044-2316-5Pollens - Weeds and Garden Plants, Ragweed, Mixed Ambrosia5 mL in 1 VIALINJECTION, SOLUTION518

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Ambrosia artemisiifolia pollenACTIVE INGREDIENTK20Y81ACO3POLLENS - WEEDS AND GARDEN PLANTS, SHORT RAGWEED, AMBROSIA ARTEMISIIFOLIA (SHORT RAGWEED, AMBROSIA ARTEMISIIFOLIA) INJECTION, SOLUTION POLLENS - WEEDS AND GARDEN PLANTS, SHORT RAGWEED, AMBROSIA ARTEMISIIFOLIA (SHORT RAGWEED, AMBROSIA ARTEMISIIFOLIA) INJECTION, SOLUTION POLLENS - WEEDS AND GARDEN PLANTS, RAGWEED, MIXED AMBROSIA (RAGWEED, MIXED AMBROSIA ) INJECTION, SOLUTION [JUBILANT HOLLISTERSTIER LLC]3
Ambrosia trifida pollenACTIVE INGREDIENTKU1V1898XXPOLLENS - WEEDS AND GARDEN PLANTS, SHORT RAGWEED, AMBROSIA ARTEMISIIFOLIA (SHORT RAGWEED, AMBROSIA ARTEMISIIFOLIA) INJECTION, SOLUTION POLLENS - WEEDS AND GARDEN PLANTS, SHORT RAGWEED, AMBROSIA ARTEMISIIFOLIA (SHORT RAGWEED, AMBROSIA ARTEMISIIFOLIA) INJECTION, SOLUTION POLLENS - WEEDS AND GARDEN PLANTS, RAGWEED, MIXED AMBROSIA (RAGWEED, MIXED AMBROSIA ) INJECTION, SOLUTION [JUBILANT HOLLISTERSTIER LLC]3
Ambrosia artemisiifolia pollenACTIVE MOIETYK20Y81ACO3POLLENS - WEEDS AND GARDEN PLANTS, SHORT RAGWEED, AMBROSIA ARTEMISIIFOLIA (SHORT RAGWEED, AMBROSIA ARTEMISIIFOLIA) INJECTION, SOLUTION POLLENS - WEEDS AND GARDEN PLANTS, SHORT RAGWEED, AMBROSIA ARTEMISIIFOLIA (SHORT RAGWEED, AMBROSIA ARTEMISIIFOLIA) INJECTION, SOLUTION POLLENS - WEEDS AND GARDEN PLANTS, RAGWEED, MIXED AMBROSIA (RAGWEED, MIXED AMBROSIA ) INJECTION, SOLUTION [JUBILANT HOLLISTERSTIER LLC]3
Ambrosia trifida pollenACTIVE MOIETYKU1V1898XXPOLLENS - WEEDS AND GARDEN PLANTS, SHORT RAGWEED, AMBROSIA ARTEMISIIFOLIA (SHORT RAGWEED, AMBROSIA ARTEMISIIFOLIA) INJECTION, SOLUTION POLLENS - WEEDS AND GARDEN PLANTS, SHORT RAGWEED, AMBROSIA ARTEMISIIFOLIA (SHORT RAGWEED, AMBROSIA ARTEMISIIFOLIA) INJECTION, SOLUTION POLLENS - WEEDS AND GARDEN PLANTS, RAGWEED, MIXED AMBROSIA (RAGWEED, MIXED AMBROSIA ) INJECTION, SOLUTION [JUBILANT HOLLISTERSTIER LLC]3
glycerinINACTIVE INGREDIENTPDC6A3C0OXPOLLENS - WEEDS AND GARDEN PLANTS, SHORT RAGWEED, AMBROSIA ARTEMISIIFOLIA (SHORT RAGWEED, AMBROSIA ARTEMISIIFOLIA) INJECTION, SOLUTION POLLENS - WEEDS AND GARDEN PLANTS, SHORT RAGWEED, AMBROSIA ARTEMISIIFOLIA (SHORT RAGWEED, AMBROSIA ARTEMISIIFOLIA) INJECTION, SOLUTION POLLENS - WEEDS AND GARDEN PLANTS, RAGWEED, MIXED AMBROSIA (RAGWEED, MIXED AMBROSIA ) INJECTION, SOLUTION [JUBILANT HOLLISTERSTIER LLC]3
phenolINACTIVE INGREDIENT339NCG44TVPOLLENS - WEEDS AND GARDEN PLANTS, SHORT RAGWEED, AMBROSIA ARTEMISIIFOLIA (SHORT RAGWEED, AMBROSIA ARTEMISIIFOLIA) INJECTION, SOLUTION POLLENS - WEEDS AND GARDEN PLANTS, SHORT RAGWEED, AMBROSIA ARTEMISIIFOLIA (SHORT RAGWEED, AMBROSIA ARTEMISIIFOLIA) INJECTION, SOLUTION POLLENS - WEEDS AND GARDEN PLANTS, RAGWEED, MIXED AMBROSIA (RAGWEED, MIXED AMBROSIA ) INJECTION, SOLUTION [JUBILANT HOLLISTERSTIER LLC]3
sodium bicarbonateINACTIVE INGREDIENT8MDF5V39QOPOLLENS - WEEDS AND GARDEN PLANTS, SHORT RAGWEED, AMBROSIA ARTEMISIIFOLIA (SHORT RAGWEED, AMBROSIA ARTEMISIIFOLIA) INJECTION, SOLUTION POLLENS - WEEDS AND GARDEN PLANTS, SHORT RAGWEED, AMBROSIA ARTEMISIIFOLIA (SHORT RAGWEED, AMBROSIA ARTEMISIIFOLIA) INJECTION, SOLUTION POLLENS - WEEDS AND GARDEN PLANTS, RAGWEED, MIXED AMBROSIA (RAGWEED, MIXED AMBROSIA ) INJECTION, SOLUTION [JUBILANT HOLLISTERSTIER LLC]3
sodium chlorideINACTIVE INGREDIENT451W47IQ8XPOLLENS - WEEDS AND GARDEN PLANTS, SHORT RAGWEED, AMBROSIA ARTEMISIIFOLIA (SHORT RAGWEED, AMBROSIA ARTEMISIIFOLIA) INJECTION, SOLUTION POLLENS - WEEDS AND GARDEN PLANTS, SHORT RAGWEED, AMBROSIA ARTEMISIIFOLIA (SHORT RAGWEED, AMBROSIA ARTEMISIIFOLIA) INJECTION, SOLUTION POLLENS - WEEDS AND GARDEN PLANTS, RAGWEED, MIXED AMBROSIA (RAGWEED, MIXED AMBROSIA ) INJECTION, SOLUTION [JUBILANT HOLLISTERSTIER LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65044-2316POLLENS - WEEDS AND GARDEN PLANTS, SHORT RAGWEED, AMBROSIA ARTEMISIIFOLIA (SHORT RAGWEED, AMBROSIA ARTEMISIIFOLIA) INJECTION, SOLUTION POLLENS - WEEDS AND GARDEN PLANTS, RAGWEED, MIXED AMBROSIA (RAGWEED, MIXED AMBROSIA) INJECTION, SOLUTION [JUBILANT HOLLISTERSTIER LLC]16Legacy NDC, 1 package rows20241103_4801db3b-3738-49e0-b047-1bfb4f85349a.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103880Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896195giant ragweed pollen extract 20,000 UNT/mL / western ragweed pollen extract 20,000 UNT/mL Injectable SolutionPSN4801db3b-3738-49e0-b047-1bfb4f85349a18
896177giant ragweed pollen extract 50 MG/ML / short ragweed pollen extract 50 MG/ML Injectable SolutionPSN4801db3b-3738-49e0-b047-1bfb4f85349a18
896201giant ragweed pollen extract 500 UNT/ML / short ragweed pollen extract 500 UNT/ML Injectable SolutionPSN4801db3b-3738-49e0-b047-1bfb4f85349a18
896138short ragweed pollen extract 50 MG/ML Injectable SolutionPSN4801db3b-3738-49e0-b047-1bfb4f85349a18
896150short ragweed pollen extract 500 UNT/ML Injectable SolutionPSN4801db3b-3738-49e0-b047-1bfb4f85349a18
896195giant ragweed pollen extract 20000 UNT/ML / western ragweed pollen extract 20000 UNT/ML Injectable SolutionSCD4801db3b-3738-49e0-b047-1bfb4f85349a18
896177giant ragweed pollen extract 50 MG/ML / western ragweed pollen extract 50 MG/ML Injectable SolutionSCD4801db3b-3738-49e0-b047-1bfb4f85349a18
896201giant ragweed pollen extract 500 UNT/ML / western ragweed pollen extract 500 UNT/ML Injectable SolutionSCD4801db3b-3738-49e0-b047-1bfb4f85349a18
896138short ragweed pollen extract 50 MG/ML Injectable SolutionSCD4801db3b-3738-49e0-b047-1bfb4f85349a18
896150short ragweed pollen extract 500 UNT/ML Injectable SolutionSCD4801db3b-3738-49e0-b047-1bfb4f85349a18
896177Ambrosia artemisiifolia pollen extract 0.05 GM/ML / Ambrosia trifida pollen extract 0.05 GM/ML Injectable SolutionSY4801db3b-3738-49e0-b047-1bfb4f85349a18
896138Ambrosia artemisiifolia pollen extract 0.05 GM/ML Injectable SolutionSY4801db3b-3738-49e0-b047-1bfb4f85349a18
896195Ambrosia artemisiifolia pollen extract 20,000 PNU/ML / Ambrosia trifida pollen extract 20,000 PNU/ML Injectable SolutionSY4801db3b-3738-49e0-b047-1bfb4f85349a18
896195Ambrosia artemisiifolia pollen extract 20,000 UNT/ML / Ambrosia trifida pollen extract 20,000 UNT/ML Injectable SolutionSY4801db3b-3738-49e0-b047-1bfb4f85349a18
896177Ambrosia artemisiifolia pollen extract 50 MG/ML / Ambrosia trifida pollen extract 50 MG/ML Injectable SolutionSY4801db3b-3738-49e0-b047-1bfb4f85349a18
896138Ambrosia artemisiifolia pollen extract 50 MG/ML Injectable SolutionSY4801db3b-3738-49e0-b047-1bfb4f85349a18
896201Ambrosia artemisiifolia pollen extract 500 UNT/ML / Ambrosia trifida pollen extract 500 UNT/ML Injectable SolutionSY4801db3b-3738-49e0-b047-1bfb4f85349a18
896150Ambrosia artemisiifolia pollen extract 500 UNT/ML Injectable SolutionSY4801db3b-3738-49e0-b047-1bfb4f85349a18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65044-2316-5650442316055 mL in 1 VIAL (65044-2316-5) 5 ml1977-10-180000-00-00NoNoCurrent