FDA.reportPublic FDA data

CENTER-AL - RUMEX ACETOSELLA POLLEN

Product NDC
0268-0063
Requested package NDC
0268-0063-10
11-digit product format
002680063
Labeler code
0268
Product ID
0268-0063_69c27f1b-06eb-4f5f-aa13-bf6f142553df
Type
NON-STANDARDIZED ALLERGENIC
Nonproprietary name
RUMEX ACETOSELLA POLLEN
Dosage form
INJECTION, SUSPENSION
Route
SUBCUTANEOUS
Labeler
ALK-Abello, Inc.
Application
BLA103753
Marketing category
BLA
Marketing start
1975-01-15
Substance
RUMEX ACETOSELLA 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0268-00630268-0063-10DDiscontinued 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
0268-0063-30CENTER-AL - RUMEX ACETOSELLA POLLEN30 mL in 1 VIAL, MULTI-DOSEINJECTION, SUSPENSION304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0268-0063CENTER-AL - POPULUS DELTOIDES SSP. MONILIFERA POLLEN (POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN) INJECTION, SUSPENSION CENTER-AL - RUMEX ACETOSELLA POLLEN (RUMEX ACETOSELLA POLLEN) INJECTION, SUSPENSION CENTER-AL - RUMEX CRISPUS POLLEN (RUMEX CRISPUS POLLEN) INJECTION, SUSPENSION CENTER-AL - ULMUS AMERICANA POLLEN (ULMUS AMERICANA POLLEN) INJECTION, SUSPENSION CENTER-AL - ULMUS PUMILA POLLEN (ULMUS PUMILA POLLEN) INJECTION, SUSPENSION CENTER-AL - CORYLUS AMERICANA POLLEN (CORYLUS AMERICANA POLLEN) INJECTION, SUSPENSION CENTER-AL - CARYA OVATA POLLEN (CARYA OVATA POLLEN) INJECTION, SUSPENSION CENTER-AL - HOUSE DUST (HOUSE DUST) INJECTION, SUSPENSION CENTER-AL - SORGHUM HALEPENSE POLLEN (SORGHUM HALEPENSE POLLEN) INJECTION, SUSPENSION CENTER-AL - POA PRATENSIS POLLEN (POA PRATENSIS POLLEN) INJECTION, SUSPENSION CENTER-AL - KOCHIA SCOPARIA POLLEN (BASSIA SCOPARIA POLLEN) INJECTION, SUSPENSION [ALK-ABELLO, INC.]4Current NDC, Legacy NDC, 1 package rows20230517_ed8e3ac0-176a-4910-a3f6-06def0a2873c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2560513American elm pollen extract 10000 UNT/mL Injectable SuspensionPSNed8e3ac0-176a-4910-a3f6-06def0a2873c4
2560551burning bush pollen extract 10000 UNT/mL Injectable SuspensionPSNed8e3ac0-176a-4910-a3f6-06def0a2873c4
2560530hazelnut pollen extract 10000 UNT/mL Injectable SuspensionPSNed8e3ac0-176a-4910-a3f6-06def0a2873c4
2560557Johnson grass pollen extract 10000 UNT/mL Injectable SuspensionPSNed8e3ac0-176a-4910-a3f6-06def0a2873c4
898411Kentucky bluegrass pollen extract 10000 UNT/mL Injectable SuspensionPSNed8e3ac0-176a-4910-a3f6-06def0a2873c4
898413Kentucky bluegrass pollen extract 20000 UNT/mL Injectable SuspensionPSNed8e3ac0-176a-4910-a3f6-06def0a2873c4
2560543plains cottonwood pollen extract 10000 UNT/mL Injectable SuspensionPSNed8e3ac0-176a-4910-a3f6-06def0a2873c4
2560539shagbark hickory pollen extract 10000 UNT/mL Injectable SuspensionPSNed8e3ac0-176a-4910-a3f6-06def0a2873c4
2560509sheep sorrel pollen extract 10,000 UNT/mL Injectable SuspensionPSNed8e3ac0-176a-4910-a3f6-06def0a2873c4
2560736Siberian elm pollen extract 10000 UNT/mL Injectable SuspensionPSNed8e3ac0-176a-4910-a3f6-06def0a2873c4
2560517yellow dock pollen extract 10000 UNT/mL Injectable SuspensionPSNed8e3ac0-176a-4910-a3f6-06def0a2873c4
2560513American elm pollen extract 10000 UNT/ML Injectable SuspensionSCDed8e3ac0-176a-4910-a3f6-06def0a2873c4
2560551burning bush pollen extract 10000 UNT/ML Injectable SuspensionSCDed8e3ac0-176a-4910-a3f6-06def0a2873c4
2560530hazelnut pollen extract 10000 UNT/ML Injectable SuspensionSCDed8e3ac0-176a-4910-a3f6-06def0a2873c4
2560557Johnson grass pollen extract 10000 UNT/ML Injectable SuspensionSCDed8e3ac0-176a-4910-a3f6-06def0a2873c4
898411Kentucky bluegrass pollen extract 10000 UNT/ML Injectable SuspensionSCDed8e3ac0-176a-4910-a3f6-06def0a2873c4
898413Kentucky bluegrass pollen extract 20000 UNT/ML Injectable SuspensionSCDed8e3ac0-176a-4910-a3f6-06def0a2873c4
2560543plains cottonwood pollen extract 10000 UNT/ML Injectable SuspensionSCDed8e3ac0-176a-4910-a3f6-06def0a2873c4
2560539shagbark hickory pollen extract 10000 UNT/ML Injectable SuspensionSCDed8e3ac0-176a-4910-a3f6-06def0a2873c4
2560509sheep sorrel pollen extract 10000 UNT/ML Injectable SuspensionSCDed8e3ac0-176a-4910-a3f6-06def0a2873c4
2560736Siberian elm pollen extract 10000 UNT/ML Injectable SuspensionSCDed8e3ac0-176a-4910-a3f6-06def0a2873c4
2560517yellow dock pollen extract 10000 UNT/ML Injectable SuspensionSCDed8e3ac0-176a-4910-a3f6-06def0a2873c4
2560551Bassia scoparia pollen extract 10,000 UNT/ML Injectable SuspensionSYed8e3ac0-176a-4910-a3f6-06def0a2873c4
2560539Carya ovata pollen extract 10,000 UNT/ML Injectable SuspensionSYed8e3ac0-176a-4910-a3f6-06def0a2873c4
2560530Corylus americana pollen extract 10,000 UNT/ML Injectable SuspensionSYed8e3ac0-176a-4910-a3f6-06def0a2873c4
2560557Johnson grass pollen extract 10,000 UNT/ML Injectable SuspensionSYed8e3ac0-176a-4910-a3f6-06def0a2873c4
898411june grass pollen extract 10,000 UNT/ML Injectable SuspensionSYed8e3ac0-176a-4910-a3f6-06def0a2873c4
898413june grass pollen extract 20,000 UNT/ML Injectable SuspensionSYed8e3ac0-176a-4910-a3f6-06def0a2873c4
2560551Kochia scoparia pollen extract 10,000 UNT/ML Injectable SuspensionSYed8e3ac0-176a-4910-a3f6-06def0a2873c4
898411Poa pratensis pollen extract 10,000 UNT/ML Injectable SuspensionSYed8e3ac0-176a-4910-a3f6-06def0a2873c4
898413Poa pratensis pollen extract 20,000 UNT/ML Injectable SuspensionSYed8e3ac0-176a-4910-a3f6-06def0a2873c4
2560543Populus deltoides subsp. monilifera pollen extract 10,000 UNT/ML Injectable SuspensionSYed8e3ac0-176a-4910-a3f6-06def0a2873c4
2560509Rumex acetosella pollen extract 10,000 UNT/ML Injectable SuspensionSYed8e3ac0-176a-4910-a3f6-06def0a2873c4
2560517Rumex crispus pollen extract 10,000 UNT/ML Injectable SuspensionSYed8e3ac0-176a-4910-a3f6-06def0a2873c4
2560557Sorghum halepense pollen extract 10,000 UNT/ML Injectable SuspensionSYed8e3ac0-176a-4910-a3f6-06def0a2873c4
2560513Ulmus americana pollen extract 10,000 UNT/ML Injectable SuspensionSYed8e3ac0-176a-4910-a3f6-06def0a2873c4
2560736Ulmus pumila pollen extract 10,000 UNT/ML Injectable SuspensionSYed8e3ac0-176a-4910-a3f6-06def0a2873c4
2560543western cottonwood pollen extract 10,000 UNT/ML Injectable SuspensionSYed8e3ac0-176a-4910-a3f6-06def0a2873c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0268-0063-100026800631010 mL in 1 VIAL, MULTI-DOSE (0268-0063-10) 10 ml1975-01-150000-00-00NoNoCurrent