FDA.reportPublic FDA data

CENTER-AL - AMBROSIA ACANTHICARPA POLLEN

Product NDC
0268-0153
11-digit product format
002680153
Labeler code
0268
Product ID
0268-0153_3e57188f-318a-4ebf-902d-a9ff158f98d2
Type
NON-STANDARDIZED ALLERGENIC
Nonproprietary name
AMBROSIA ACANTHICARPA POLLEN
Dosage form
INJECTION, SUSPENSION
Route
SUBCUTANEOUS
Labeler
ALK-Abello, Inc.
Application
BLA103753
Marketing category
BLA
Marketing start
1975-01-15
Marketing end
0000-00-00
Substance
AMBROSIA ACANTHICARPA POLLEN
Active strength
10000 [PNU]/mL
Pharmacologic classes
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0268-0153-30CENTER-AL - AMBROSIA ACANTHICARPA POLLEN30 mL in 1 VIAL, MULTI-DOSEINJECTION, SUSPENSION304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0268-0153CENTER-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.]4Legacy 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
0268-0153-300026801533030 mL in 1 VIAL, MULTI-DOSE (0268-0153-30) 30 ml1975-01-150000-00-00NoNoCurrent