Home NDC 0268-8027 GRASS MIX Number 4-S
Product NDC 0268-8027
11-digit product format 002688027
Labeler code 0268
Product ID 0268-8027_f4170117-0559-46bb-a4fb-66138c6a9874
Type STANDARDIZED ALLERGENIC
Nonproprietary name AGROSTIS GIGANTEA POLLEN, DACTYLIS GLOMERATA POLLEN, PHLEUM PRATENSE POLLEN and POA PRATENSIS 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; 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 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 · 2 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 product product 0268-8027 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0268-8027 0268-8027-50 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Additional Listing Data#
Finished product Yes
Brand name base GRASS MIX Number 4-S
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POA PRATENSIS POLLEN 25000 [BAU]/mL AGROSTIS GIGANTEA POLLEN 25000 [BAU]/mL DACTYLIS GLOMERATA POLLEN 25000 [BAU]/mL PHLEUM PRATENSE POLLEN 25000 [BAU]/mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0268-8027-50 GRASS MIX Number 4-S 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 0268-8027 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, 1 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 0268-8027-50 00268802750 53 mL in 1 VIAL (0268-8027-50) 53 ml 1997-12-18 0000-00-00 No No Current