FDA.reportPublic FDA data

RAGWITEK

Product NDC
52709-1601
11-digit product format
527091601
Labeler code
52709
Product ID
52709-1601_521ab801-bd3d-48a9-b210-07ef7f87a989
Type
STANDARDIZED ALLERGENIC
Nonproprietary name
AMBROSIA ARTEMISIIFOLIA POLLEN
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
ALK-Abello A S
Application
BLA125478
Marketing category
BLA
Marketing start
2014-04-17
Substance
AMBROSIA ARTEMISIIFOLIA POLLEN
Active strength
12 [Amb'a'1'U]/1
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52709-1601IInactivated by FDA2026-08-17
excluded packagepackage52709-160152709-1601-3IInactivated by FDA2026-08-17
excluded packagepackage52709-160152709-1601-5IInactivated by FDA2026-08-17

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52709-1601-1RAGWITEK10 in 1 BLISTER PACKTABLET109
52709-1601-3RAGWITEK3 in 1 CARTONTABLET39
52709-1601-5RAGWITEK5 in 1 BLISTER PACKTABLET59
52709-1601-5RAGWITEK1 in 1 CARTONTABLET19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52709-1601-1EA - Each52709-160126228374-7e91-47e7-96b2-429863c28f0b12017-11-06
52709-1601-3EA - Each52709-16014ef99200-a1f5-4356-86a1-fe66c28ab53d12017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52709-1601RAGWITEK (AMBROSIA ARTEMISIIFOLIA POLLEN) TABLET [ALK-ABELLO A S]9Current NDC, Legacy NDC, 4 package rows20220921_70216cba-11b5-40fd-8656-9f27b24f7b60.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125478RagwitekShort Ragweed Pollen Allergen Extract351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1495470Ragwitek 12 Amb a 1-U Sublingual TabletPSN70216cba-11b5-40fd-8656-9f27b24f7b609
1495463short ragweed pollen extract 12 Amb a 1-U Sublingual TabletPSN70216cba-11b5-40fd-8656-9f27b24f7b609
1495470short ragweed pollen extract 12 Amb a 1-U Sublingual Tablet [Ragwitek]SBD70216cba-11b5-40fd-8656-9f27b24f7b609
1495463short ragweed pollen extract 12 Amb a 1-U Sublingual TabletSCD70216cba-11b5-40fd-8656-9f27b24f7b609
1495463Ambrosia artemisiifolia pollen allergenic extract 12 Amb a 1-U Sublingual TabletSY70216cba-11b5-40fd-8656-9f27b24f7b609
1495470Ragwitek 12 Amb a 1-U Sublingual TabletSY70216cba-11b5-40fd-8656-9f27b24f7b609

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52709-1601-15270916010110 in 1 BLISTER PACKHistorical
52709-1601-3527091601033 BLISTER PACK in 1 CARTON (52709-1601-3) / 10 TABLET in 1 BLISTER PACK (52709-1601-1) 3 blister pack2014-04-170000-00-00NoNoCurrent
52709-1601-5527091601051 BLISTER PACK in 1 CARTON (52709-1601-5) / 5 TABLET in 1 BLISTER PACK1 blister pack2014-04-170000-00-00NoNoCurrent
52709-1601-9527091601099 BLISTER PACK in 1 CARTON (52709-1601-9) > 10 TABLET in 1 BLISTER PACK (52709-1601-1) 9 blister pack2014-04-170000-00-00NoNoCurrent