Home NDC 0268-8076-06 MIX OF 7 STANDARDIZED GRASS POLLEN
Product NDC 0268-8076
Requested package NDC 0268-8076-06
11-digit product format 002688076
Labeler code 0268
Product ID 0268-8076_f4170117-0559-46bb-a4fb-66138c6a9874
Type STANDARDIZED ALLERGENIC
Nonproprietary name AGROSTIS GIGANTEA POLLEN, DACTYLIS GLOMERATA POLLEN, FESTUCA PRATENSIS, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, POA PRATENSIS POLLEN and ANTHOXANTHUM ODORATUM POLLEN
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler ALK-Abello, Inc.
Application BLA103058
Marketing category BLA
Marketing start 1997-12-18
Substance AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; DACTYLIS GLOMERATA POLLEN; FESTUCA PRATENSIS POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN
Active strength 14286; 14286; 14286; 14286; 14286; 14286; 14286 [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL
Pharmacologic classes 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], 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], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], 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], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC], Standardized Pollen Allergenic Extract [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0268-8076 0268-8076-06 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Additional Listing Data#
Finished product Yes
Brand name base MIX OF 7 STANDARDIZED GRASS POLLEN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHLEUM PRATENSE POLLEN 14286 [BAU]/mL DACTYLIS GLOMERATA POLLEN 14286 [BAU]/mL POA PRATENSIS POLLEN 14286 [BAU]/mL AGROSTIS GIGANTEA POLLEN 14286 [BAU]/mL FESTUCA PRATENSIS POLLEN 14286 [BAU]/mL LOLIUM PERENNE POLLEN 14286 [BAU]/mL ANTHOXANTHUM ODORATUM POLLEN 14286 [BAU]/mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0268-8076-06 MIX OF 7 STANDARDIZED GRASS POLLEN 5.5 mL in 1 VIAL INJECTION, SOLUTION 5.5 6 0268-8076-10 MIX OF 7 STANDARDIZED GRASS POLLEN 10.5 mL in 1 VIAL INJECTION, SOLUTION 10.5 6 0268-8076-50 MIX OF 7 STANDARDIZED GRASS POLLEN 53 mL in 1 VIAL INJECTION, SOLUTION 53 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0268-8076 MIX OF 5 STANDARDIZED GRASS POLLEN (AGROSTIS GIGANTEA POLLEN, ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, PHLEUM PRATENSE POLLEN AND POA PRATENSIS POLLEN) INJECTION, SOLUTION MIX OF 6 STANDARDIZED GRASS POLLEN (AGROSTIS GIGANTEA POLLEN, DACTYLIS GLOMERATA POLLEN, FESTUCA PRATENSIS, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN AND POA PRATENSIS POLLEN) INJECTION, SOLUTION MIX OF 7 STANDARDIZED GRASS POLLEN (AGROSTIS GIGANTEA POLLEN, DACTYLIS GLOMERATA POLLEN, FESTUCA PRATENSIS, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, POA PRATENSIS POLLEN AND ANTHOXANTHUM ODORATUM POLLEN) INJECTION, SOLUTION MIDWEST MIX OF STANDARDIZED GRASS (AGROSTIS GIGANTEA POLLEN, DACTYLIS GLOMERATA POLLEN, PHLEUM PRATENSE POLLEN AND POA PRATENSIS POLLEN) INJECTION, SOLUTION GRASS MIX NUMBER 4-S (AGROSTIS GIGANTEA POLLEN, DACTYLIS GLOMERATA POLLEN, PHLEUM PRATENSE POLLEN AND POA PRATENSIS POLLEN) INJECTION, SOLUTION [ALK-ABELLO, INC.] 6 Current NDC, Legacy NDC, 3 package rows 20200715_77618828-d658-4f15-9500-a07ef11a0a0c.zip
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 103058 Pollens - Grasses, Timothy Phleum pratense 351(a) Rx 2026-08-01
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0268-8076-06 00268807606 5.5 mL in 1 VIAL (0268-8076-06) 5.5 ml 1997-12-18 0000-00-00 No No Current