Home NDC 0268-8015-30 8 SOUTHERN GRASS MIX
Product NDC 0268-8015
Requested package NDC 0268-8015-30
11-digit product format 002688015
Labeler code 0268
Product ID 0268-8015_fb07a9de-091d-494d-a237-dba963cea4e7
Type NON-STANDARDIZED ALLERGENIC
Nonproprietary name AGROSTIS GIGANTEA POLLEN, CYNODON DACTYLON, DACTYLIS GLOMERATA, FESTUCA PRATENSIS, LOLIUM PERENNE, PHLEUM PRATENSE, POA PRATENSIS, SORGHUM HALEPENSE 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 CYNODON DACTYLON WHOLE; SORGHUM HALEPENSE POLLEN; PHLEUM PRATENSE; DACTYLIS GLOMERATA; POA PRATENSIS; AGROSTIS GIGANTEA POLLEN; FESTUCA PRATENSIS; LOLIUM PERENNE
Active strength 10000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL
Pharmacologic classes Standardized Pollen Allergenic Extract [EPC],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 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 NDC Product Description Form Quantity Strength SPL version 0268-8015-30 8 SOUTHERN GRASS MIX 32 mL in 1 VIAL INJECTION, SOLUTION 32 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0268-8015 5 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.] 4 Legacy NDC, 1 package rows 20230527_edcb6de3-85d9-4acb-97c2-27fc67218d79.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0268-8015-30 00268801530 32 mL in 1 VIAL (0268-8015-30) 32 ml 1975-01-15 0000-00-00 No No Current