FDA.reportPublic FDA data

CENTER-AL - AMBROSIA ARTEMISIIFOLIA POLLEN

Product NDC
0268-0156
11-digit product format
002680156
Labeler code
0268
Product ID
0268-0156_070eea8d-3fd1-452d-89de-1dbf1c19efb2
Type
NON-STANDARDIZED ALLERGENIC
Nonproprietary name
AMBROSIA ARTEMISIIFOLIA POLLEN
Dosage form
INJECTION, SUSPENSION
Route
SUBCUTANEOUS
Labeler
ALK-Abello, Inc.
Application
BLA103753
Marketing category
BLA
Marketing start
1975-01-15
Substance
AMBROSIA ARTEMISIIFOLIA POLLEN
Active strength
20000 [PNU]/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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CENTER-AL - AMBROSIA ARTEMISIIFOLIA POLLEN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMBROSIA ARTEMISIIFOLIA POLLEN20000 [PNU]/mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0268-0156-30CENTER-AL - AMBROSIA ARTEMISIIFOLIA POLLEN30 mL in 1 VIAL, MULTI-DOSEINJECTION, SUSPENSION304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0268-0156CENTER-AL - DACTYLIS GLOMERATA POLLEN (DACTYLIS GLOMERATA POLLEN) INJECTION, SUSPENSION CENTER-AL - CARYA ILLINOINENSIS POLLEN (CARYA ILLINOINENSIS POLLEN) INJECTION, SUSPENSION CENTER-AL - AMARANTHUS RETROFLEXUS POLLEN (AMARANTHUS RETROFLEXUS POLLEN) INJECTION, SUSPENSION CENTER-AL - PLANTAGO LANCEOLATA POLLEN (PLANTAGO LANCEOLATA POLLEN) INJECTION, SUSPENSION CENTER-AL - POPULUS ALBA POLLEN (POPULUS ALBA POLLEN) INJECTION, SUSPENSION CENTER-AL - AMBROSIA ACANTHICARPA POLLEN (AMBROSIA ACANTHICARPA POLLEN) INJECTION, SUSPENSION CENTER-AL - AMBROSIA ARTEMISIIFOLIA POLLEN (AMBROSIA ARTEMISIIFOLIA POLLEN) INJECTION, SUSPENSION CENTER-AL - AMBROSIA TRIFIDA POLLEN (AMBROSIA TRIFIDA POLLEN) INJECTION, SUSPENSION CENTER-AL - AMBROSIA PSILOSTACHYA POLLEN (AMBROSIA PSILOSTACHYA POLLEN) INJECTION, SUSPENSION [ALK-ABELLO, INC.]4Current NDC, Legacy NDC, 1 package rows20230519_5af653fc-ffa5-470d-9414-e7ce4f3b929f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2560722English plantain pollen extract 10 UNT/mL Injectable SuspensionPSN5af653fc-ffa5-470d-9414-e7ce4f3b929f4
2560724English plantain pollen extract 10,000 UNT/mL Injectable SuspensionPSN5af653fc-ffa5-470d-9414-e7ce4f3b929f4
2560723English plantain pollen extract 100 UNT/mL Injectable SuspensionPSN5af653fc-ffa5-470d-9414-e7ce4f3b929f4
2560520English plantain pollen extract 1000 UNT/mL Injectable SuspensionPSN5af653fc-ffa5-470d-9414-e7ce4f3b929f4
2560715false ragweed pollen extract 10000 UNT/mL Injectable SuspensionPSN5af653fc-ffa5-470d-9414-e7ce4f3b929f4
2560711giant ragweed pollen extract 10000 UNT/mL Injectable SuspensionPSN5af653fc-ffa5-470d-9414-e7ce4f3b929f4
2560712giant ragweed pollen extract 20,000 UNT/mL Injectable SuspensionPSN5af653fc-ffa5-470d-9414-e7ce4f3b929f4
897504orchard grass pollen extract 20,000 UNT/mL Injectable SuspensionPSN5af653fc-ffa5-470d-9414-e7ce4f3b929f4
2560559pecan pollen extract 10000 UNT/mL Injectable SuspensionPSN5af653fc-ffa5-470d-9414-e7ce4f3b929f4
2560507redroot pigweed pollen extract 10000 UNT/mL Injectable SuspensionPSN5af653fc-ffa5-470d-9414-e7ce4f3b929f4
895918redroot pigweed pollen extract 5000 UNT/mL Injectable SuspensionPSN5af653fc-ffa5-470d-9414-e7ce4f3b929f4
896142short ragweed pollen extract 10,000 UNT/mL Injectable SuspensionPSN5af653fc-ffa5-470d-9414-e7ce4f3b929f4
2560713short ragweed pollen extract 20000 UNT/mL Injectable SuspensionPSN5af653fc-ffa5-470d-9414-e7ce4f3b929f4
2560515western ragweed pollen extract 10000 UNT/mL Injectable SuspensionPSN5af653fc-ffa5-470d-9414-e7ce4f3b929f4
2560545white poplar pollen extract 10000 UNT/mL Injectable SuspensionPSN5af653fc-ffa5-470d-9414-e7ce4f3b929f4
2560722English plantain pollen extract 10 UNT/ML Injectable SuspensionSCD5af653fc-ffa5-470d-9414-e7ce4f3b929f4
2560723English plantain pollen extract 100 UNT/ML Injectable SuspensionSCD5af653fc-ffa5-470d-9414-e7ce4f3b929f4
2560520English plantain pollen extract 1000 UNT/ML Injectable SuspensionSCD5af653fc-ffa5-470d-9414-e7ce4f3b929f4
2560724English plantain pollen extract 10000 UNT/ML Injectable SuspensionSCD5af653fc-ffa5-470d-9414-e7ce4f3b929f4
2560715false ragweed pollen extract 10000 UNT/ML Injectable SuspensionSCD5af653fc-ffa5-470d-9414-e7ce4f3b929f4
2560711giant ragweed pollen extract 10000 UNT/ML Injectable SuspensionSCD5af653fc-ffa5-470d-9414-e7ce4f3b929f4
2560712giant ragweed pollen extract 20000 UNT/ML Injectable SuspensionSCD5af653fc-ffa5-470d-9414-e7ce4f3b929f4
897504orchard grass pollen extract 20000 UNT/ML Injectable SuspensionSCD5af653fc-ffa5-470d-9414-e7ce4f3b929f4
2560559pecan pollen extract 10000 UNT/ML Injectable SuspensionSCD5af653fc-ffa5-470d-9414-e7ce4f3b929f4
2560507redroot pigweed pollen extract 10000 UNT/ML Injectable SuspensionSCD5af653fc-ffa5-470d-9414-e7ce4f3b929f4
895918redroot pigweed pollen extract 5000 UNT/ML Injectable SuspensionSCD5af653fc-ffa5-470d-9414-e7ce4f3b929f4
896142short ragweed pollen extract 10000 UNT/ML Injectable SuspensionSCD5af653fc-ffa5-470d-9414-e7ce4f3b929f4
2560713short ragweed pollen extract 20000 UNT/ML Injectable SuspensionSCD5af653fc-ffa5-470d-9414-e7ce4f3b929f4
2560515western ragweed pollen extract 10000 UNT/ML Injectable SuspensionSCD5af653fc-ffa5-470d-9414-e7ce4f3b929f4
2560545white poplar pollen extract 10000 UNT/ML Injectable SuspensionSCD5af653fc-ffa5-470d-9414-e7ce4f3b929f4
2560507Amaranthus retroflexus pollen extract 10,000 UNT/ML Injectable SuspensionSY5af653fc-ffa5-470d-9414-e7ce4f3b929f4
895918Amaranthus retroflexus pollen extract 5000 UNT/ML Injectable SuspensionSY5af653fc-ffa5-470d-9414-e7ce4f3b929f4
2560715Ambrosia acanthicarpa pollen extract 10,000 UNT/ML Injectable SuspensionSY5af653fc-ffa5-470d-9414-e7ce4f3b929f4
896142Ambrosia artemisiifolia pollen extract 10,000 UNT/ML Injectable SuspensionSY5af653fc-ffa5-470d-9414-e7ce4f3b929f4
2560713Ambrosia artemisiifolia pollen extract 20,000 UNT/ML Injectable SuspensionSY5af653fc-ffa5-470d-9414-e7ce4f3b929f4
2560515Ambrosia psilostachya pollen extract 10,000 UNT/ML Injectable SuspensionSY5af653fc-ffa5-470d-9414-e7ce4f3b929f4
2560711Ambrosia trifida pollen extract 10,000 UNT/ML Injectable SuspensionSY5af653fc-ffa5-470d-9414-e7ce4f3b929f4
2560712Ambrosia trifida pollen extract 20,000 UNT/ML Injectable SuspensionSY5af653fc-ffa5-470d-9414-e7ce4f3b929f4
2560559Carya illinoinensis pollen extract 10,000 UNT/ML Injectable SuspensionSY5af653fc-ffa5-470d-9414-e7ce4f3b929f4
897504Dactylis glomerata pollen extract 20,000 UNT/ML Injectable SuspensionSY5af653fc-ffa5-470d-9414-e7ce4f3b929f4
2560722Plantago lanceolata pollen extract 10 UNT/ML Injectable SuspensionSY5af653fc-ffa5-470d-9414-e7ce4f3b929f4
2560724Plantago lanceolata pollen extract 10,000 UNT/ML Injectable SuspensionSY5af653fc-ffa5-470d-9414-e7ce4f3b929f4
2560723Plantago lanceolata pollen extract 100 UNT/ML Injectable SuspensionSY5af653fc-ffa5-470d-9414-e7ce4f3b929f4
2560520Plantago lanceolata pollen extract 1000 UNT/ML Injectable SuspensionSY5af653fc-ffa5-470d-9414-e7ce4f3b929f4
2560545Populus alba pollen extract 10,000 UNT/ML Injectable SuspensionSY5af653fc-ffa5-470d-9414-e7ce4f3b929f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0268-0156-300026801563030 mL in 1 VIAL, MULTI-DOSE (0268-0156-30) 30 ml1975-01-150000-00-00NoNoCurrent