FDA.reportPublic FDA data

9 TREE MIX

Product NDC
0268-8020
11-digit product format
002688020
Labeler code
0268
Product ID
0268-8020_8762013a-24c8-4dae-a319-789065564b34
Type
NON-STANDARDIZED ALLERGENIC
Nonproprietary name
ACER SACCHARINUM POLLEN, ALNUS RHOMBIFOLIA POLLEN, BETULA LENTA WHOLE, CARYA OVATA POLLEN, FRAXINUS AMERICANA POLLEN, PLATANUS OCCIDENTALIS POLLEN, POPULUS ALBA POLLEN, QUERCUS ALBA POLLEN, ULMUS AMERICANA POLLEN
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
ALK-Abello, Inc.
Application
BLA103753
Marketing category
BLA
Marketing start
1965-01-01
Substance
ACER SACCHARINUM POLLEN; ALNUS RHOMBIFOLIA POLLEN; BETULA LENTA WHOLE; CARYA OVATA POLLEN; FRAXINUS AMERICANA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; QUERCUS ALBA POLLEN; ULMUS AMERICANA POLLEN
Active strength
40000; 40000; 40000; 40000; 40000; 40000; 40000; 40000; 40000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL
Pharmacologic classes
Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], 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 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], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
9 TREE MIX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACER SACCHARINUM POLLEN40000 [PNU]/mL
ALNUS RHOMBIFOLIA POLLEN40000 [PNU]/mL
BETULA LENTA WHOLE40000 [PNU]/mL
CARYA OVATA POLLEN40000 [PNU]/mL
FRAXINUS AMERICANA POLLEN40000 [PNU]/mL
PLATANUS OCCIDENTALIS POLLEN40000 [PNU]/mL
POPULUS ALBA POLLEN40000 [PNU]/mL
QUERCUS ALBA POLLEN40000 [PNU]/mL
ULMUS AMERICANA POLLEN40000 [PNU]/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
0268-8020-509 TREE MIX53 mL in 1 VIALINJECTION, SOLUTION535

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0268-8020MIXED ASPERGILLUS (ASPERGILLUS FLAVUS VAR. ORYZAE, ASPERGILLUS NIGER VAR. NIGER, ASPERGILLUS REPENS, ASPERGILLUS TERREUS) INJECTION, SOLUTION MIXED FEATHERS (ANAS PLATYRHYNCHOS FEATHER, ANSER ANSER FEATHER, GALLUS GALLUS FEATHER) INJECTION, SOLUTION 4 WEED MIX (AMARANTHUS RETROFLEXUS POLLEN, CHENOPODIUM ALBUM POLLEN, PLANTAGO LANCEOLATA POLLEN AND XANTHIUM STRUMARIUM POLLEN) .......NUM VAR. CHRYSOGENUM) INJECTION, SOLUTION MOLD MIX 2 (AUREOBASIDIUM PULLULANS, CURVULARIA INAEQUALIS, FUSARIUM ROSEUM, MUCOR PLUMBEUS, PHIZOPUS ORYZAE) INJECTION, SOLUTION FAPP MIXTURE (ASPERGILLUS FLAVUS VAR. ORYZAE, ASPERGILLUS NIGER VAR. NIGER, ASPERGILLUS REPENS, ASPERGILLUS TERREUS, GIBBERELLA ZEAE, PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM, PHOMA EXIGUA VAR. EXIGUA) INJECTION, SOLUTION [ALK-ABELLO, INC.]5Current NDC, Legacy NDC, 1 package rows20230525_5f15c12a-8df0-41de-9d59-7de47e5e89ca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1922788giant ragweed pollen extract 100 UNT/ML / short ragweed pollen extract 100 UNT/ML Injectable SolutionPSN5f15c12a-8df0-41de-9d59-7de47e5e89ca5
1922791giant ragweed pollen extract 40000 UNT/ML / short ragweed pollen extract 40000 UNT/ML Injectable SolutionPSN5f15c12a-8df0-41de-9d59-7de47e5e89ca5
1922797pecan pollen extract 100 UNT/ML / shagbark hickory pollen extract 100 UNT/ML Injectable SolutionPSN5f15c12a-8df0-41de-9d59-7de47e5e89ca5
966954Penicillium chrysogenum var. chrysogenum allergenic extract 20,000 UNT/mL Injectable SolutionPSN5f15c12a-8df0-41de-9d59-7de47e5e89ca5
966960Penicillium chrysogenum var. chrysogenum allergenic extract 40,000 UNT/mL Injectable SolutionPSN5f15c12a-8df0-41de-9d59-7de47e5e89ca5
1922788giant ragweed pollen extract 100 UNT/ML / short ragweed pollen extract 100 UNT/ML Injectable SolutionSCD5f15c12a-8df0-41de-9d59-7de47e5e89ca5
1922791giant ragweed pollen extract 40000 UNT/ML / short ragweed pollen extract 40000 UNT/ML Injectable SolutionSCD5f15c12a-8df0-41de-9d59-7de47e5e89ca5
1922797pecan pollen extract 100 UNT/ML / shagbark hickory pollen extract 100 UNT/ML Injectable SolutionSCD5f15c12a-8df0-41de-9d59-7de47e5e89ca5
966954Penicillium chrysogenum var. chrysogenum allergenic extract 20000 UNT/ML Injectable SolutionSCD5f15c12a-8df0-41de-9d59-7de47e5e89ca5
966960Penicillium chrysogenum var. chrysogenum allergenic extract 40000 UNT/ML Injectable SolutionSCD5f15c12a-8df0-41de-9d59-7de47e5e89ca5
1922788Ambrosia artemisiifolia pollen extract 100 PNU/ML / Ambrosia trifida pollen extract 100 PNU/ML Injectable SolutionSY5f15c12a-8df0-41de-9d59-7de47e5e89ca5
1922788Ambrosia artemisiifolia pollen extract 100 UNT/ML / Ambrosia trifida pollen extract 100 UNT/ML Injectable SolutionSY5f15c12a-8df0-41de-9d59-7de47e5e89ca5
1922791Ambrosia artemisiifolia pollen extract 40000 PNU/ML / Ambrosia trifida pollen extract 40000 PNU/ML Injectable SolutionSY5f15c12a-8df0-41de-9d59-7de47e5e89ca5
1922791Ambrosia artemisiifolia pollen extract 40000 UNT/ML / Ambrosia trifida pollen extract 40000 UNT/ML Injectable SolutionSY5f15c12a-8df0-41de-9d59-7de47e5e89ca5
1922797Carya illinoinensis pollen UNT/ML / Carya ovata pollen extract 100 UNT/ML Injectable SolutionSY5f15c12a-8df0-41de-9d59-7de47e5e89ca5
966954Penicillium chrysogenum var. chrysogenum extract 20,000 UNT/ML Injectable SolutionSY5f15c12a-8df0-41de-9d59-7de47e5e89ca5
966960Penicillium chrysogenum var. chrysogenum extract 40,000 UNT/ML Injectable SolutionSY5f15c12a-8df0-41de-9d59-7de47e5e89ca5
966954Penicillium notatum allergenic extract 20,000 UNT/ML Injectable SolutionSY5f15c12a-8df0-41de-9d59-7de47e5e89ca5
966960Penicillium notatum allergenic extract 40,000 UNT/ML Injectable SolutionSY5f15c12a-8df0-41de-9d59-7de47e5e89ca5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0268-8020-500026880205053 mL in 1 VIAL (0268-8020-50) 53 ml1965-01-010000-00-00NoNoCurrent