FDA.reportPublic FDA data

Pollens - Weeds and Garden Plants, Short Ragweed, Ambrosia artemisiifolia

Product NDC
65044-2297
11-digit product format
650442297
Labeler code
65044
Product ID
65044-2297_5e6a7a02-f790-4786-96ea-11aa48dfa5d9
Type
STANDARDIZED ALLERGENIC
Nonproprietary name
Short Ragweed, Ambrosia artemisiifolia
Dosage form
INJECTION, SOLUTION
Route
PERCUTANEOUS; SUBCUTANEOUS
Labeler
Jubilant HollisterStier LLC
Application
BLA103880
Marketing category
BLA
Marketing start
1977-10-18
Substance
AMBROSIA ARTEMISIIFOLIA POLLEN
Active strength
.05 g/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pollens - Weeds and Garden Plants, Short Ragweed, Ambrosia artemisiifolia
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMBROSIA ARTEMISIIFOLIA POLLEN.05 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
65044-2297-1Pollens - Weeds and Garden Plants, Short Ragweed, Ambrosia artemisiifolia5 mL in 1 VIALINJECTION, SOLUTION518
65044-2297-2Pollens - Weeds and Garden Plants, Short Ragweed, Ambrosia artemisiifolia10 mL in 1 VIALINJECTION, SOLUTION1018
65044-2297-4Pollens - Weeds and Garden Plants, Short Ragweed, Ambrosia artemisiifolia50 mL in 1 VIALINJECTION, SOLUTION5018

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
65044-2297POLLENS - 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]16Current NDC, Legacy NDC, 3 package rows20241103_4801db3b-3738-49e0-b047-1bfb4f85349a.zip

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
65044-2297-1650442297015 mL in 1 VIAL (65044-2297-1) 5 ml1977-10-180000-00-00NoNoCurrent
65044-2297-26504422970210 mL in 1 VIAL (65044-2297-2) 10 ml1977-10-180000-00-00NoNoCurrent
65044-2297-36504422970330 mL in 1 VIAL (65044-2297-3) 30 ml1977-10-180000-00-00NoNoCurrent
65044-2297-46504422970450 mL in 1 VIAL (65044-2297-4) 50 ml1977-10-180000-00-00NoNoCurrent