FDA.reportPublic FDA data

Standardized Grass Pollen, Grass Mix 4

Product NDC
65044-0842
11-digit product format
650440842
Labeler code
65044
Product ID
65044-0842_3c14e8ca-64c9-463f-963d-5a2e31d01ad3
Type
STANDARDIZED ALLERGENIC
Nonproprietary name
Standardized Grass Pollen, Grass Mix 4
Dosage form
INJECTION, SOLUTION
Route
PERCUTANEOUS; SUBCUTANEOUS
Labeler
Jubilant HollisterStier LLC
Application
BLA103873
Marketing category
BLA
Marketing start
1998-01-15
Substance
AGROSTIS GIGANTEA POLLEN; DACTYLIS GLOMERATA POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN
Active strength
25000; 25000; 25000; 25000 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL
Pharmacologic classes
Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], 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, Grass Mix 4
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AGROSTIS GIGANTEA POLLEN25000 [BAU]/mL
DACTYLIS GLOMERATA POLLEN25000 [BAU]/mL
PHLEUM PRATENSE POLLEN25000 [BAU]/mL
POA PRATENSIS POLLEN25000 [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
65044-0842-1Standardized Grass Pollen, Grass Mix 45 mL in 1 VIALINJECTION, SOLUTION514
65044-0842-2Standardized Grass Pollen, Grass Mix 410 mL in 1 VIALINJECTION, SOLUTION1014
65044-0842-3Standardized Grass Pollen, Grass Mix 430 mL in 1 VIALINJECTION, SOLUTION3014
65044-0842-4Standardized Grass Pollen, Grass Mix 450 mL in 1 VIALINJECTION, SOLUTION5014
65044-0842-1Standardized Grass Pollen, Grass Mix 45 mL in 1 VIALINJECTION, SOLUTION511
65044-0842-2Standardized Grass Pollen, Grass Mix 410 mL in 1 VIALINJECTION, SOLUTION1011
65044-0842-3Standardized Grass Pollen, Grass Mix 430 mL in 1 VIALINJECTION, SOLUTION3011
65044-0842-4Standardized Grass Pollen, Grass Mix 450 mL in 1 VIALINJECTION, SOLUTION5011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65044-0842STANDARDIZED GRASS POLLEN, GRASS MIX 4 INJECTION, SOLUTION [JUBILANT HOLLISTERSTIER LLC]10Current NDC, Legacy NDC, 4 package rows20241103_2fdd4672-7977-4b93-aed4-0556c98f091f.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
65044-0842-1650440842015 mL in 1 VIAL (65044-0842-1) 5 ml1998-01-150000-00-00NoNoCurrent
65044-0842-26504408420210 mL in 1 VIAL (65044-0842-2) 10 ml1998-01-150000-00-00NoNoCurrent
65044-0842-36504408420330 mL in 1 VIAL (65044-0842-3) 30 ml1998-01-150000-00-00NoNoCurrent
65044-0842-46504408420450 mL in 1 VIAL (65044-0842-4) 50 ml1998-01-150000-00-00NoNoCurrent