FDA.reportPublic FDA data

CENTER-AL - PHLEUM PRATENSE POLLEN

Product NDC
0268-0192
11-digit product format
002680192
Labeler code
0268
Product ID
0268-0192_92d8302b-b86a-43fb-b86e-a2021367d178
Type
NON-STANDARDIZED ALLERGENIC
Nonproprietary name
PHLEUM PRATENSE POLLEN
Dosage form
INJECTION, SUSPENSION
Route
SUBCUTANEOUS
Labeler
ALK-Abello, Inc.
Application
BLA103753
Marketing category
BLA
Marketing start
1975-01-15
Substance
PHLEUM PRATENSE POLLEN
Active strength
10000 [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 - PHLEUM PRATENSE POLLEN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHLEUM PRATENSE POLLEN10000 [PNU]/mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0268-0192-30CENTER-AL - PHLEUM PRATENSE POLLEN30 mL in 1 VIAL, MULTI-DOSEINJECTION, SUSPENSION304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0268-0192CENTER-AL - AGROSTIS GIGANTEA (AGROSTIS GIGANTEA TOP) INJECTION, SUSPENSION CENTER-AL - SALSOLA KALI POLLEN (SALSOLA KALI POLLEN) INJECTION, SUSPENSION CENTER-AL - LOLIUM PERENNE POLLEN (LOLIUM PERENNE POLLEN) INJECTION, SUSPENSION CENTER-AL - ARTEMISIA TRIDENTATA POLLEN (ARTEMISIA TRIDENTATA POLLEN) INJECTION, SUSPENSION CENTER-AL - ATRIPLEX WRIGHTII POLLEN (ATRIPLEX WRIGHTII POLLEN) INJECTION, SUSPENSION CENTER-AL - PLATANUS OCCIDENTALIS POLLEN (PLATANUS OCCIDENTALIS POLLEN) INJECTION, SUSPENSION CENTER-AL - PLATANUS RACEMOSA POLLEN (PLATANUS RACEMOSA POLLEN) INJECTION, SUSPENSION CENTER-AL - PHLEUM PRATENSE POLLEN (PHLEUM PRATENSE POLLEN) INJECTION, SUSPENSION CENTER-AL - HOLCUS LANATUS POLLEN (HOLCUS LANATUS POLLEN) INJECTION, SUSPENSION CENTER-AL - JUGLANS NIGRA POLLEN (JUGLANS NIGRA POLLEN) INJECTION, SUSPENSION CENTER-AL - JUGLANS CALIFORNICA POLLEN (JUGLANS CALIFORNICA POLLEN) INJECTION, SUSPENSION CENTER-AL - SALIX NIGRA POLLEN (SALIX NIGRA POLLEN) INJECTION, SUSPENSION [ALK-ABELLO, INC.]4Current NDC, Legacy NDC, 1 package rows20230519_6c30d6b8-e1bb-4c87-84a0-05261f3609fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2560532black walnut pollen extract 10000 UNT/mL Injectable SuspensionPSN6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560522black willow pollen extract 10000 UNT/mL Injectable SuspensionPSN6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560524California black walnut pollen extract 10000 UNT/mL Injectable SuspensionPSN6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560549common sagebrush pollen extract 10000 UNT/mL Injectable SuspensionPSN6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560717eastern sycamore pollen extract 10000 UNT/mL Injectable SuspensionPSN6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560552perennial rye grass pollen extract 10000 UNT/mL Injectable SuspensionPSN6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
898008perennial rye grass pollen extract 20,000 UNT/mL Injectable SuspensionPSN6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
1191181redtop grass pollen extract 20000 UNT/ML Injectable SuspensionPSN6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560734Russian thistle pollen extract 10000 UNT/mL Injectable SuspensionPSN6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560536saltbush pollen extract 10000 UNT/mL Injectable SuspensionPSN6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560537saltbush pollen extract 20,000 UNT/mL Injectable SuspensionPSN6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
898318Timothy grass pollen extract 10,000 UNT/mL Injectable SuspensionPSN6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
898322Timothy grass pollen extract 20,000 UNT/mL Injectable SuspensionPSN6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
897943velvet grass pollen extract 10,000 UNT/mL Injectable SuspensionPSN6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560721western sycamore pollen extract 10000 UNT/mL Injectable SuspensionPSN6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560532black walnut pollen extract 10000 UNT/ML Injectable SuspensionSCD6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560522black willow pollen extract 10000 UNT/ML Injectable SuspensionSCD6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560524California black walnut pollen extract 10000 UNT/ML Injectable SuspensionSCD6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560549common sagebrush pollen extract 10000 UNT/ML Injectable SuspensionSCD6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560717eastern sycamore pollen extract 10000 UNT/ML Injectable SuspensionSCD6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560552perennial rye grass pollen extract 10000 UNT/ML Injectable SuspensionSCD6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
898008perennial rye grass pollen extract 20000 UNT/ML Injectable SuspensionSCD6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
1191181redtop grass pollen extract 20000 UNT/ML Injectable SuspensionSCD6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560734Russian thistle pollen extract 10000 UNT/ML Injectable SuspensionSCD6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560536saltbush pollen extract 10000 UNT/ML Injectable SuspensionSCD6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560537saltbush pollen extract 20000 UNT/ML Injectable SuspensionSCD6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
898318Timothy grass pollen extract 10000 UNT/ML Injectable SuspensionSCD6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
898322Timothy grass pollen extract 20000 UNT/ML Injectable SuspensionSCD6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
897943velvet grass pollen extract 10000 UNT/ML Injectable SuspensionSCD6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560721western sycamore pollen extract 10000 UNT/ML Injectable SuspensionSCD6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
1191181Agrostis gigantea pollen extract 20,000 UNT/ML Injectable SuspensionSY6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560717American sycamore pollen extract 10000 UNT/ML Injectable SuspensionSY6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560549Artemisia tridentata pollen extract 10,000 UNT/ML Injectable SuspensionSY6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560536Atriplex wrightii pollen extract 10,000 UNT/ML Injectable SuspensionSY6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560537Atriplex wrightii pollen extract 20,000 UNT/ML Injectable SuspensionSY6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
897943Holcus lanatus pollen extract 10,000 UNT/ML Injectable SuspensionSY6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560524Juglans californica pollen extract 10,000 UNT/ML Injectable SuspensionSY6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560532Juglans nigra pollen extract 10,000 UNT/ML Injectable SuspensionSY6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560552Lolium perenne pollen extract 10000 UNT/ML Injectable SuspensionSY6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
898008Lolium perenne pollen extract 20,000 UNT/ML Injectable SuspensionSY6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
898318Phleum pratense pollen extract 10,000 UNT/ML Injectable SuspensionSY6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
898322Phleum pratense pollen extract 20,000 UNT/ML Injectable SuspensionSY6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560717Platanus occidentalis pollen extract 10,000 UNT/ML Injectable SuspensionSY6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560721Platanus racemosa pollen extract 10,000 UNT/ML Injectable SuspensionSY6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560734Russian thistle pollen extract 10,000 UNT/ML Injectable SuspensionSY6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560522Salix nigra pollen extract 10,000 UNT/ML Injectable SuspensionSY6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560734Salsola kali pollen extract 10,000 UNT/ML Injectable SuspensionSY6c30d6b8-e1bb-4c87-84a0-05261f3609fa4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0268-0192-100026801921010 mL in 1 VIAL, MULTI-DOSE (0268-0192-10) 10 ml1975-01-150000-00-00NoNoCurrent
0268-0192-300026801923030 mL in 1 VIAL, MULTI-DOSE (0268-0192-30) 30 ml1975-01-150000-00-00NoNoCurrent