FDA.reportPublic FDA data

CENTER-AL - JUGLANS NIGRA POLLEN

Product NDC
0268-0199
Requested package NDC
0268-0199-30
11-digit product format
002680199
Labeler code
0268
Product ID
0268-0199_92d8302b-b86a-43fb-b86e-a2021367d178
Type
NON-STANDARDIZED ALLERGENIC
Nonproprietary name
JUGLANS NIGRA POLLEN
Dosage form
INJECTION, SUSPENSION
Route
SUBCUTANEOUS
Labeler
ALK-Abello, Inc.
Application
BLA103753
Marketing category
BLA
Marketing start
1975-01-15
Substance
JUGLANS NIGRA POLLEN
Active strength
10000 [PNU]/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0268-01990268-0199-30DDiscontinued by firm2026-08-03
excluded packagepackage0268-01990268-0199-30DDiscontinued by firm2026-08-03

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0268-0199-30CENTER-AL - JUGLANS NIGRA POLLEN30 mL in 1 VIAL, MULTI-DOSEINJECTION, SUSPENSION304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0268-0199CENTER-AL - AGROSTIS GIGANTEA (AGROSTIS GIGANTEA TOP) INJECTION, SUSPENSION CENTER-AL - SALSOLA KALI POLLEN (SALSOLA KALI POLLEN) INJECTION, SUSPENSION CENTER-AL - LOLIUM PERENNE POLLEN (LOLIUM PERENNE POLLEN) INJECTION, SUSPENSION CENTER-AL - ARTEMISIA TRIDENTATA POLLEN (ARTEMISIA TRIDENTATA POLLEN) INJECTION, SUSPENSION CENTER-AL - ATRIPLEX WRIGHTII POLLEN (ATRIPLEX WRIGHTII POLLEN) INJECTION, SUSPENSION CENTER-AL - PLATANUS OCCIDENTALIS POLLEN (PLATANUS OCCIDENTALIS POLLEN) INJECTION, SUSPENSION CENTER-AL - PLATANUS RACEMOSA POLLEN (PLATANUS RACEMOSA POLLEN) INJECTION, SUSPENSION CENTER-AL - PHLEUM PRATENSE POLLEN (PHLEUM PRATENSE POLLEN) INJECTION, SUSPENSION CENTER-AL - HOLCUS LANATUS POLLEN (HOLCUS LANATUS POLLEN) INJECTION, SUSPENSION CENTER-AL - JUGLANS NIGRA POLLEN (JUGLANS NIGRA POLLEN) INJECTION, SUSPENSION CENTER-AL - JUGLANS CALIFORNICA POLLEN (JUGLANS CALIFORNICA POLLEN) INJECTION, SUSPENSION CENTER-AL - SALIX NIGRA POLLEN (SALIX NIGRA POLLEN) INJECTION, SUSPENSION [ALK-ABELLO, INC.]4Current NDC, Legacy NDC, 1 package rows20230519_6c30d6b8-e1bb-4c87-84a0-05261f3609fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2560532black walnut pollen extract 10000 UNT/mL Injectable SuspensionPSN6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560522black willow pollen extract 10000 UNT/mL Injectable SuspensionPSN6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560524California black walnut pollen extract 10000 UNT/mL Injectable SuspensionPSN6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560549common sagebrush pollen extract 10000 UNT/mL Injectable SuspensionPSN6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560717eastern sycamore pollen extract 10000 UNT/mL Injectable SuspensionPSN6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560552perennial rye grass pollen extract 10000 UNT/mL Injectable SuspensionPSN6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
898008perennial rye grass pollen extract 20,000 UNT/mL Injectable SuspensionPSN6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
1191181redtop grass pollen extract 20000 UNT/ML Injectable SuspensionPSN6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560734Russian thistle pollen extract 10000 UNT/mL Injectable SuspensionPSN6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560536saltbush pollen extract 10000 UNT/mL Injectable SuspensionPSN6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560537saltbush pollen extract 20,000 UNT/mL Injectable SuspensionPSN6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
898318Timothy grass pollen extract 10,000 UNT/mL Injectable SuspensionPSN6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
898322Timothy grass pollen extract 20,000 UNT/mL Injectable SuspensionPSN6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
897943velvet grass pollen extract 10,000 UNT/mL Injectable SuspensionPSN6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560721western sycamore pollen extract 10000 UNT/mL Injectable SuspensionPSN6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560532black walnut pollen extract 10000 UNT/ML Injectable SuspensionSCD6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560522black willow pollen extract 10000 UNT/ML Injectable SuspensionSCD6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560524California black walnut pollen extract 10000 UNT/ML Injectable SuspensionSCD6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560549common sagebrush pollen extract 10000 UNT/ML Injectable SuspensionSCD6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560717eastern sycamore pollen extract 10000 UNT/ML Injectable SuspensionSCD6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560552perennial rye grass pollen extract 10000 UNT/ML Injectable SuspensionSCD6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
898008perennial rye grass pollen extract 20000 UNT/ML Injectable SuspensionSCD6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
1191181redtop grass pollen extract 20000 UNT/ML Injectable SuspensionSCD6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560734Russian thistle pollen extract 10000 UNT/ML Injectable SuspensionSCD6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560536saltbush pollen extract 10000 UNT/ML Injectable SuspensionSCD6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560537saltbush pollen extract 20000 UNT/ML Injectable SuspensionSCD6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
898318Timothy grass pollen extract 10000 UNT/ML Injectable SuspensionSCD6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
898322Timothy grass pollen extract 20000 UNT/ML Injectable SuspensionSCD6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
897943velvet grass pollen extract 10000 UNT/ML Injectable SuspensionSCD6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560721western sycamore pollen extract 10000 UNT/ML Injectable SuspensionSCD6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
1191181Agrostis gigantea pollen extract 20,000 UNT/ML Injectable SuspensionSY6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560717American sycamore pollen extract 10000 UNT/ML Injectable SuspensionSY6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560549Artemisia tridentata pollen extract 10,000 UNT/ML Injectable SuspensionSY6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560536Atriplex wrightii pollen extract 10,000 UNT/ML Injectable SuspensionSY6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560537Atriplex wrightii pollen extract 20,000 UNT/ML Injectable SuspensionSY6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
897943Holcus lanatus pollen extract 10,000 UNT/ML Injectable SuspensionSY6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560524Juglans californica pollen extract 10,000 UNT/ML Injectable SuspensionSY6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560532Juglans nigra pollen extract 10,000 UNT/ML Injectable SuspensionSY6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560552Lolium perenne pollen extract 10000 UNT/ML Injectable SuspensionSY6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
898008Lolium perenne pollen extract 20,000 UNT/ML Injectable SuspensionSY6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
898318Phleum pratense pollen extract 10,000 UNT/ML Injectable SuspensionSY6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
898322Phleum pratense pollen extract 20,000 UNT/ML Injectable SuspensionSY6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560717Platanus occidentalis pollen extract 10,000 UNT/ML Injectable SuspensionSY6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560721Platanus racemosa pollen extract 10,000 UNT/ML Injectable SuspensionSY6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560734Russian thistle pollen extract 10,000 UNT/ML Injectable SuspensionSY6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560522Salix nigra pollen extract 10,000 UNT/ML Injectable SuspensionSY6c30d6b8-e1bb-4c87-84a0-05261f3609fa4
2560734Salsola kali pollen extract 10,000 UNT/ML Injectable SuspensionSY6c30d6b8-e1bb-4c87-84a0-05261f3609fa4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0268-0199-300026801993030 mL in 1 VIAL, MULTI-DOSE (0268-0199-30) 30 ml1975-01-150000-00-00NoNoCurrent