FDA.reportPublic FDA data

CENTER-AL - FESTUCA PRATENSIS POLLEN

Product NDC
0268-0104
11-digit product format
002680104
Labeler code
0268
Product ID
0268-0104_12a51e21-1817-4ded-8bf2-a2ad5fc6525c
Type
NON-STANDARDIZED ALLERGENIC
Nonproprietary name
FESTUCA PRATENSIS 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
FESTUCA PRATENSIS POLLEN
Active strength
10000 [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]
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
0268-0104-30CENTER-AL - FESTUCA PRATENSIS POLLEN30 mL in 1 VIAL, MULTI-DOSEINJECTION, SUSPENSION304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0268-0104CENTER-AL - CHENOPODIUM ALBUM POLLEN (CHENOPODIUM ALBUM POLLEN) INJECTION, SUSPENSION CENTER-AL - ACER SACCHARUM POLLEN (ACER SACCHARUM POLLEN) INJECTION, SUSPENSION CENTER-AL - FESTUCA PRATENSIS POLLEN (FESTUCA PRATENSIS POLLEN) INJECTION, SUSPENSION CENTER-AL - PROSOPIS JULIFLORA POLLEN (PROSOPIS JULIFLORA POLLEN) INJECTION, SUSPENSION CENTER-AL - ARTEMISIA VULGARIS POLLEN (ARTEMISIA VULGARIS POLLEN) INJECTION, SUSPENSION CENTER-AL - MORUS RUBRA POLLEN (MORUS RUBRA POLLEN) INJECTION, SUSPENSION CENTER-AL - QUERCUS AGRIFOLIA POLLEN (QUERCUS AGRIFOLIA POLLEN) INJECTION, SUSPENSION CENTER-AL - QUERCUS VIRGINIANA POLLEN (QUERCUS VIRGINIANA POLLEN) INJECTION, SUSPENSION CENTER-AL - QUERCUS ALBA POLLEN (QUERCUS ALBA POLLEN) INJECTION, SUSPENSION CENTER-AL - AVENA SATIVA POLLEN (AVENA SATIVA POLLEN) INJECTION, SUSPENSION CENTER-AL - OLEA EUROPAEA POLLEN (OLEA EUROPAEA POLLEN) INJECTION, SUSPENSION [ALK-ABELLO, INC.]4Legacy NDC, 1 package rows20230520_71a32d27-68d0-459a-908d-c66301f2abd2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1095375coast live oak pollen extract 10000 UNT/ML Injectable SuspensionPSN71a32d27-68d0-459a-908d-c66301f2abd24
2560555cultivated oat pollen extract 10000 UNT/mL Injectable SuspensionPSN71a32d27-68d0-459a-908d-c66301f2abd24
898124European olive pollen extract 10 UNT/mL Injectable SuspensionPSN71a32d27-68d0-459a-908d-c66301f2abd24
898126European olive pollen extract 100 UNT/mL Injectable SuspensionPSN71a32d27-68d0-459a-908d-c66301f2abd24
2560518European olive pollen extract 1000 UNT/mL Injectable SuspensionPSN71a32d27-68d0-459a-908d-c66301f2abd24
2560727European olive pollen extract 10000 UNT/mL Injectable SuspensionPSN71a32d27-68d0-459a-908d-c66301f2abd24
2560506hard maple pollen extract 10000 UNT/mL Injectable SuspensionPSN71a32d27-68d0-459a-908d-c66301f2abd24
2560547lambs quarters pollen extract 10000 UNT/mL Injectable SuspensionPSN71a32d27-68d0-459a-908d-c66301f2abd24
2560729live oak pollen extract 10000 UNT/mL Injectable SuspensionPSN71a32d27-68d0-459a-908d-c66301f2abd24
897850meadow fescue grass pollen extract 10000 UNT/mL Injectable SuspensionPSN71a32d27-68d0-459a-908d-c66301f2abd24
897852meadow fescue grass pollen extract 20000 UNT/mL Injectable SuspensionPSN71a32d27-68d0-459a-908d-c66301f2abd24
1095407mesquite pollen extract 10000 UNT/ML Injectable SuspensionPSN71a32d27-68d0-459a-908d-c66301f2abd24
2560731mugwort sage pollen extract 10000 UNT/mL Injectable SuspensionPSN71a32d27-68d0-459a-908d-c66301f2abd24
2560534red mulberry pollen extract 10000 UNT/mL Injectable SuspensionPSN71a32d27-68d0-459a-908d-c66301f2abd24
2560528white oak pollen extract 10000 UNT/mL Injectable SuspensionPSN71a32d27-68d0-459a-908d-c66301f2abd24
1095375coast live oak pollen extract 10000 UNT/ML Injectable SuspensionSCD71a32d27-68d0-459a-908d-c66301f2abd24
2560555cultivated oat pollen extract 10000 UNT/ML Injectable SuspensionSCD71a32d27-68d0-459a-908d-c66301f2abd24
898124european olive pollen extract 10 UNT/ML Injectable SuspensionSCD71a32d27-68d0-459a-908d-c66301f2abd24
898126european olive pollen extract 100 UNT/ML Injectable SuspensionSCD71a32d27-68d0-459a-908d-c66301f2abd24
2560518european olive pollen extract 1000 UNT/ML Injectable SuspensionSCD71a32d27-68d0-459a-908d-c66301f2abd24
2560727european olive pollen extract 10000 UNT/ML Injectable SuspensionSCD71a32d27-68d0-459a-908d-c66301f2abd24
2560506hard maple pollen extract 10000 UNT/ML Injectable SuspensionSCD71a32d27-68d0-459a-908d-c66301f2abd24
2560547lambs quarters pollen extract 10000 UNT/ML Injectable SuspensionSCD71a32d27-68d0-459a-908d-c66301f2abd24
2560729live oak pollen extract 10000 UNT/ML Injectable SuspensionSCD71a32d27-68d0-459a-908d-c66301f2abd24
897850meadow fescue grass pollen extract 10000 UNT/ML Injectable SuspensionSCD71a32d27-68d0-459a-908d-c66301f2abd24
897852meadow fescue grass pollen extract 20000 UNT/ML Injectable SuspensionSCD71a32d27-68d0-459a-908d-c66301f2abd24
1095407mesquite pollen extract 10000 UNT/ML Injectable SuspensionSCD71a32d27-68d0-459a-908d-c66301f2abd24
2560731mugwort sage pollen extract 10000 UNT/ML Injectable SuspensionSCD71a32d27-68d0-459a-908d-c66301f2abd24
2560534red mulberry pollen extract 10000 UNT/ML Injectable SuspensionSCD71a32d27-68d0-459a-908d-c66301f2abd24
2560528white oak pollen extract 10000 UNT/ML Injectable SuspensionSCD71a32d27-68d0-459a-908d-c66301f2abd24
2560506Acer saccharum pollen extract 10,000 UNT/ML Injectable SuspensionSY71a32d27-68d0-459a-908d-c66301f2abd24
2560731Artemisia vulgaris pollen extract 10,000 UNT/ML Injectable SuspensionSY71a32d27-68d0-459a-908d-c66301f2abd24
2560555Avena sativa pollen extract 10,000 UNT/ML Injectable SuspensionSY71a32d27-68d0-459a-908d-c66301f2abd24
2560547Chenopodium album pollen extract 10,000 UNT/ML Injectable SuspensionSY71a32d27-68d0-459a-908d-c66301f2abd24
1095375coast live oak pollen extract 10,000 UNT/ML Injectable SuspensionSY71a32d27-68d0-459a-908d-c66301f2abd24
897850Festuca elatior pollen extract 10,000 UNT/ML Injectable SuspensionSY71a32d27-68d0-459a-908d-c66301f2abd24
897852Festuca elatior pollen extract 20,000 UNT/ML Injectable SuspensionSY71a32d27-68d0-459a-908d-c66301f2abd24
897850Festuca pratensis pollen extract 10,000 UNT/ML Injectable SuspensionSY71a32d27-68d0-459a-908d-c66301f2abd24
897852Festuca pratensis pollen extract 20,000 UNT/ML Injectable SuspensionSY71a32d27-68d0-459a-908d-c66301f2abd24
897850Lolium pratense pollen extract 10000 UNT/ML Injectable SuspensionSY71a32d27-68d0-459a-908d-c66301f2abd24
897852Lolium pratense pollen extract 20,000 UNT/ML Injectable SuspensionSY71a32d27-68d0-459a-908d-c66301f2abd24
1095407mesquite pollen extract 10,000 UNT/ML Injectable SuspensionSY71a32d27-68d0-459a-908d-c66301f2abd24
2560534Morus rubra pollen extract 10,000 UNT/ML Injectable SuspensionSY71a32d27-68d0-459a-908d-c66301f2abd24
898124Olea europaea pollen extract 10 UNT/ML Injectable SuspensionSY71a32d27-68d0-459a-908d-c66301f2abd24
2560727Olea europaea pollen extract 10,000 UNT/ML Injectable SuspensionSY71a32d27-68d0-459a-908d-c66301f2abd24
898126Olea europaea pollen extract 100 UNT/ML Injectable SuspensionSY71a32d27-68d0-459a-908d-c66301f2abd24
2560518Olea europaea pollen extract 1000 UNT/ML Injectable SuspensionSY71a32d27-68d0-459a-908d-c66301f2abd24
2560528Quercus alba pollen extract 10,000 UNT/ML Injectable SuspensionSY71a32d27-68d0-459a-908d-c66301f2abd24
2560729Quercus virginiana pollen extract 10,000 UNT/ML Injectable SuspensionSY71a32d27-68d0-459a-908d-c66301f2abd24
897850Schedonorus pratensis pollen extract 10,000 UNT/ML Injectable SuspensionSY71a32d27-68d0-459a-908d-c66301f2abd24
897852Schedonorus pratensis pollen extract 20,000 UNT/ML Injectable SuspensionSY71a32d27-68d0-459a-908d-c66301f2abd24
2560506sugar maple pollen extract 10,000 UNT/ML Injectable SuspensionSY71a32d27-68d0-459a-908d-c66301f2abd24
2560528white oak pollen extract 10,000 UNT/ML Injectable SuspensionSY71a32d27-68d0-459a-908d-c66301f2abd24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0268-0104-300026801043030 mL in 1 VIAL, MULTI-DOSE (0268-0104-30) 30 ml1975-01-150000-00-00NoNoCurrent