FDA.reportPublic FDA data

Standardized Grass Pollen, Fescue, Meadow

Product NDC
65044-0612
11-digit product format
650440612
Labeler code
65044
Product ID
65044-0612_3c14e8ca-64c9-463f-963d-5a2e31d01ad3
Type
STANDARDIZED ALLERGENIC
Nonproprietary name
Standardized Grass Pollen, Fescue, Meadow
Dosage form
INJECTION, SOLUTION
Route
PERCUTANEOUS; SUBCUTANEOUS
Labeler
Jubilant HollisterStier LLC
Application
BLA103874
Marketing category
BLA
Marketing start
1998-01-15
Substance
LOLIUM PRATENSE POLLEN
Active strength
100000 [BAU]/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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Standardized Grass Pollen, Fescue, Meadow
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOLIUM PRATENSE POLLEN100000 [BAU]/mL

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65044-0612-1Standardized Grass Pollen, Fescue, Meadow5 mL in 1 VIALINJECTION, SOLUTION514
65044-0612-2Standardized Grass Pollen, Fescue, Meadow10 mL in 1 VIALINJECTION, SOLUTION1014
65044-0612-3Standardized Grass Pollen, Fescue, Meadow30 mL in 1 VIALINJECTION, SOLUTION3014
65044-0612-4Standardized Grass Pollen, Fescue, Meadow50 mL in 1 VIALINJECTION, SOLUTION5014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65044-0612STANDARDIZED GRASS POLLEN, FESCUE, MEADOW INJECTION, SOLUTION STANDARDIZED GRASS POLLEN, REDTOP INJECTION, SOLUTION STANDARDIZED GRASS POLLEN, ORCHARD GRASS INJECTION, SOLUTION STANDARDIZED GRASS POLLEN, BERMUDA GRASS INJECTION, SOLUTION STANDARDIZED GRASS POLLEN, TIMOTHY INJECTION, SOLUTION STANDARDIZED GRASS POLLEN, SWEET VERNAL GRASS INJECTION, SOLUTION STANDARDIZED GRASS POLLEN, RYEGRASS INJECTION, SOLUTION STANDARDIZED GRASS POLLEN, BLUEGRASS, KENTUCKY JUNE INJECTION, SOLUTION [JUBILANT HOLLISTERSTIER LLC]10Current NDC, Legacy NDC, 4 package rows20241105_3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897496Bermuda grass pollen extract 10000 UNT/mL Injectable SuspensionPSN3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
852837Kentucky bluegrass pollen extract 10000 BAU/mL Injectable SolutionPSN3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
853278Kentucky bluegrass pollen extract 100000 BAU/mL Injectable SolutionPSN3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
851921meadow fescue grass pollen extract 10000 BAU/ML Injectable SolutionPSN3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
854054meadow fescue grass pollen extract 100000 BAU/ML Injectable SolutionPSN3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
851881orchard grass pollen extract 10000 BAU/ML Injectable SolutionPSN3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
853047orchard grass pollen extract 100000 BAU/ML Injectable SolutionPSN3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
852822perennial rye grass pollen extract 10000 BAU/ML Injectable SolutionPSN3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
853027perennial rye grass pollen extract 100000 BAU/ML Injectable SolutionPSN3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
853029redtop grass pollen extract 10000 BAU/ML Injectable SolutionPSN3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
851873redtop grass pollen extract 100000 BAU/ML Injectable SolutionPSN3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
851901sweet vernal grass pollen extract 10000 BAU/ML Injectable SolutionPSN3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
854162sweet vernal grass pollen extract 100000 BAU/ML Injectable SolutionPSN3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
851997Timothy grass pollen extract 10000 BAU/mL Injectable SolutionPSN3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
852157Timothy grass pollen extract 100000 BAU/mL Injectable SolutionPSN3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
897496Bermuda grass pollen extract 10000 UNT/ML Injectable SuspensionSCD3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
852837Kentucky bluegrass pollen extract 10000 BAU/ML Injectable SolutionSCD3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
853278Kentucky bluegrass pollen extract 100000 BAU/ML Injectable SolutionSCD3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
851921meadow fescue grass pollen extract 10000 BAU/ML Injectable SolutionSCD3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
854054meadow fescue grass pollen extract 100000 BAU/ML Injectable SolutionSCD3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
851881orchard grass pollen extract 10000 BAU/ML Injectable SolutionSCD3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
853047orchard grass pollen extract 100000 BAU/ML Injectable SolutionSCD3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
852822perennial rye grass pollen extract 10000 BAU/ML Injectable SolutionSCD3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
853027perennial rye grass pollen extract 100000 BAU/ML Injectable SolutionSCD3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
853029redtop grass pollen extract 10000 BAU/ML Injectable SolutionSCD3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
851873redtop grass pollen extract 100000 BAU/ML Injectable SolutionSCD3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
851901sweet vernal grass pollen extract 10000 BAU/ML Injectable SolutionSCD3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
854162sweet vernal grass pollen extract 100000 BAU/ML Injectable SolutionSCD3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
851997Timothy grass pollen extract 10000 BAU/ML Injectable SolutionSCD3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
852157Timothy grass pollen extract 100000 BAU/ML Injectable SolutionSCD3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
853029Agrostis gigantea pollen extract 10,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
851873Agrostis gigantea pollen extract 100,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
851901Anthoxanthum odoratum grass pollen extract 10,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
854162Anthoxanthum odoratum grass pollen extract 100,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
897496Cynodon dactylon pollen extract 10,000 BAU/ML Injectable SuspensionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
897496Cynodon dactylon pollen extract 10,000 UNT/ML Injectable SuspensionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
851881Dactylis glomerata pollen extract 10,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
853047Dactylis glomerata pollen extract 100,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
851921Festuca elatior grass pollen extract 10,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
854054Festuca elatior grass pollen extract 100,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
851921Festuca pratensis grass pollen extract 10,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
854054Festuca pratensis grass pollen extract 100,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
852837June grass pollen extract 10,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
853278June grass pollen extract 100,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
852822Lolium perenne grass pollen extract 10,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
853027Lolium perenne grass pollen extract 100,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
851921Lolium pratense grass pollen extract 10,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
854054Lolium pratense grass pollen extract 100,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
852157Phleum pratense grass pollen extract 100,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
851997Phleum pratense pollen extract 10,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
852837Poa pratensis grass pollen extract 10,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
853278Poa pratensis grass pollen extract 100,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
851921Schedonorus pratensis grass pollen extract 10,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14
854054Schedonorus pratensis grass pollen extract 100,000 BAU/ML Injectable SolutionSY3b7a7f87-72f4-42cb-bc1b-55eefcf8d7dc14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65044-0612-1650440612015 mL in 1 VIAL (65044-0612-1) 5 ml1998-01-150000-00-00NoNoCurrent
65044-0612-26504406120210 mL in 1 VIAL (65044-0612-2) 10 ml1998-01-150000-00-00NoNoCurrent
65044-0612-36504406120330 mL in 1 VIAL (65044-0612-3) 30 ml1998-01-150000-00-00NoNoCurrent
65044-0612-46504406120450 mL in 1 VIAL (65044-0612-4) 50 ml1998-01-150000-00-00NoNoCurrent