FDA.reportPublic FDA data

Standardized Short Ragweed Pollen

Product NDC
49288-0448
11-digit product format
492880448
Labeler code
49288
Product ID
49288-0448_3a632396-c97c-4b7f-8eef-8908cf591385
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Standardized Short Ragweed Pollen
Dosage form
INJECTION, SOLUTION
Route
INTRADERMAL; SUBCUTANEOUS
Labeler
Antigen Laboratories, Inc.
Application
BLA102232
Marketing category
BLA
Marketing start
1983-01-15
Marketing end
0000-00-00
Substance
AMBROSIA ARTEMISIIFOLIA POLLEN
Active strength
100000 [AU]/mL
Pharmacologic classes
Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49288-0448-22019-10-21C16284748780-1956f9ecf-d93b-621f-e053-dbdaa90a74adAllergenic Extract
49288-0448-32019-10-21C16284748780-1956f9ecf-d93b-621f-e053-dbdaa90a74adAllergenic Extract
49288-0448-42019-10-21C16284748780-1956f9ecf-d93b-621f-e053-dbdaa90a74adAllergenic Extract
49288-0448-52019-10-21C16284748780-1956f9ecf-d93b-621f-e053-dbdaa90a74adAllergenic Extract

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49288-0448-2Standardized Short Ragweed Pollen5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION52
49288-0448-3Standardized Short Ragweed Pollen10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION102
49288-0448-4Standardized Short Ragweed Pollen30 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION302
49288-0448-5Standardized Short Ragweed Pollen50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION502

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMBROSIA ARTEMISIIFOLIA POLLENACTIVE INGREDIENTK20Y81ACO3STANDARDIZED SHORT RAGWEED POLLEN INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]2
AMBROSIA ARTEMISIIFOLIA POLLENACTIVE MOIETYK20Y81ACO3STANDARDIZED SHORT RAGWEED POLLEN INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSTANDARDIZED SHORT RAGWEED POLLEN INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]2
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOSTANDARDIZED SHORT RAGWEED POLLEN INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XSTANDARDIZED SHORT RAGWEED POLLEN INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RSTANDARDIZED SHORT RAGWEED POLLEN INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49288-0448STANDARDIZED SHORT RAGWEED POLLEN INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.]2Legacy NDC, 4 package rows20090824_4e6f2764-63a7-4d99-82c6-3b319a246296.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896144short ragweed pollen extract 100000 AU/ML Injectable SolutionPSN4e6f2764-63a7-4d99-82c6-3b319a2462962
896144short ragweed pollen extract 100000 AU/ML Injectable SolutionSCD4e6f2764-63a7-4d99-82c6-3b319a2462962
896144Ambrosia artemisiifolia pollen extract 100,000 AU/ML Injectable SolutionSY4e6f2764-63a7-4d99-82c6-3b319a2462962

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
49288-0448-2492880448025 mL in 1 VIAL, MULTI-DOSE5 mlHistorical
49288-0448-34928804480310 mL in 1 VIAL, MULTI-DOSE10 mlHistorical
49288-0448-44928804480430 mL in 1 VIAL, MULTI-DOSE30 mlHistorical
49288-0448-54928804480550 mL in 1 VIAL, MULTI-DOSE50 mlHistorical