FDA.reportPublic FDA data

9 TREE MIX

Product NDC
0268-8023
11-digit product format
002688023
Labeler code
0268
Product ID
0268-8023_fb07a9de-091d-494d-a237-dba963cea4e7
Type
NON-STANDARDIZED ALLERGENIC
Nonproprietary name
ACER SACCHARUM POLLEN, ALNUS RHOMBIFOLIA POLLEN, BETULA LENTA POLLEN, 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
1975-01-15
Marketing end
0000-00-00
Substance
ALNUS RHOMBIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; ULMUS AMERICANA POLLEN; BETULA LENTA POLLEN; ACER SACCHARUM POLLEN; CARYA OVATA POLLEN; QUERCUS ALBA POLLEN; POPULUS ALBA POLLEN; PLATANUS OCCIDENTALIS POLLEN
Active strength
10000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL
Pharmacologic classes
Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Non-Standardized Pollen Allergenic Extract [EPC],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-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
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0268-8023DDiscontinued by firm2026-10-12
excluded packagepackage0268-80230268-8023-10DDiscontinued by firm2026-10-12
excluded packagepackage0268-80230268-8023-30DDiscontinued by firm2026-10-12

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0268-8023-109 TREE MIX10.5 mL in 1 VIALINJECTION, SOLUTION10.54
0268-8023-309 TREE MIX32 mL in 1 VIALINJECTION, SOLUTION324

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0268-80235 GRASS MIX (PHLEUM PRATENSE POLLEN, DACTYLIS GLOMERATA POLLEN, POA PRATENSIS POLLEN, AGROSTIS GIGANTEA POLLEN, ANTHOXANTHUM ODORATUM POLLEN) INJECTION, SOLUTION 3 GRASS MIX (BROMUS INERMIS POLLEN, CYNODON DACTYLON, CYNODON DACTYLON) INJECTION, SOLUTION 4 WEED MIX (AMARANTHUS RETROFLEXUS POLLEN, CHENOPODIUM ALBUM POLLEN, PLANTAGO LANCEOLATA POLLEN, XANTHIUM STRUMARIUM POLLEN) .......US AMERICANA POLLEN, PLATANUS OCCIDENTALIS POLLEN, POPULUS ALBA POLLEN, QUERCUS ALBA POLLEN, ULMUS AMERICANA POLLEN) INJECTION, SOLUTION MIXED RAGWEED (AMBROSIA ARTEMISIIFOLIA, AMBROSIA TRIFIDA POLLEN) INJECTION, SOLUTION WESTERN WEED MIX (AMBROSIA ACANTHICARPA POLLEN, AMBROSIA PSILOSTACHYA POLLEN, ARTEMISIA TRIDENTATA POLLEN, BASSIA SCOPARIA POLLEN, SALSOLA KALI POLLEN) INJECTION, SOLUTION [ALK-ABELLO, INC.]4Legacy NDC, 2 package rows20230527_edcb6de3-85d9-4acb-97c2-27fc67218d79.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 SolutionPSNedcb6de3-85d9-4acb-97c2-27fc67218d794
1922790giant ragweed pollen extract 20000 UNT/ML / short ragweed pollen extract 20000 UNT/ML Injectable SolutionPSNedcb6de3-85d9-4acb-97c2-27fc67218d794
1922788giant ragweed pollen extract 100 UNT/ML / short ragweed pollen extract 100 UNT/ML Injectable SolutionSCDedcb6de3-85d9-4acb-97c2-27fc67218d794
1922790giant ragweed pollen extract 20000 UNT/ML / short ragweed pollen extract 20000 UNT/ML Injectable SolutionSCDedcb6de3-85d9-4acb-97c2-27fc67218d794
1922788Ambrosia artemisiifolia pollen extract 100 PNU/ML / Ambrosia trifida pollen extract 100 PNU/ML Injectable SolutionSYedcb6de3-85d9-4acb-97c2-27fc67218d794
1922788Ambrosia artemisiifolia pollen extract 100 UNT/ML / Ambrosia trifida pollen extract 100 UNT/ML Injectable SolutionSYedcb6de3-85d9-4acb-97c2-27fc67218d794
1922790Ambrosia artemisiifolia pollen extract 20000 PNU/ML / Ambrosia trifida pollen extract 20000 PNU/ML Injectable SolutionSYedcb6de3-85d9-4acb-97c2-27fc67218d794
1922790Ambrosia artemisiifolia pollen extract 20000 UNT/ML / Ambrosia trifida pollen extract 20000 UNT/ML Injectable SolutionSYedcb6de3-85d9-4acb-97c2-27fc67218d794

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0268-8023-100026880231010.5 mL in 1 VIAL (0268-8023-10) 10.5 ml1975-01-150000-00-00NoNoCurrent
0268-8023-300026880233032 mL in 1 VIAL (0268-8023-30) 32 ml1975-01-150000-00-00NoNoCurrent