GRASTEK

Product NDC
52709-1501
11-digit product format
527091501
Labeler code
52709
Product ID
52709-1501_6b4f4eeb-efb8-4f1f-ad69-9aa00744aa6c
Type
STANDARDIZED ALLERGENIC
Nonproprietary name
Timothy Grass Pollen Allergen Extract
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
ALK-Abello A S
Application
BLA125473
Marketing category
BLA
Marketing start
2014-04-11
Substance
PHLEUM PRATENSE POLLEN
Active strength
2800 [BAU]/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

Additional Listing Data#

Finished product
Yes
Brand name base
GRASTEK
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHLEUM PRATENSE POLLEN2800 [BAU]/1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52709-1501-1GRASTEK10 in 1 BLISTER PACKTABLET1012
52709-1501-3GRASTEK3 in 1 CARTONTABLET312
52709-1501-5GRASTEK1 in 1 CARTONTABLET112
52709-1501-5GRASTEK5 in 1 BLISTER PACKTABLET512

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52709-1501-1EA - Each52709-1501a6b86f7d-46ae-4a2a-a357-ed466e72373b12017-11-06
52709-1501-3EA - Each52709-1501f6adc0c5-31af-446c-aa24-0a9d82851ab412017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52709-1501GRASTEK (TIMOTHY GRASS POLLEN ALLERGEN EXTRACT) TABLET [ALK-ABELLO A S]12Current NDC, Legacy NDC, 4 package rows20220921_ebb02ba7-de81-4367-8ba7-d774816f85b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1495316Grastek 2800 BAU Sublingual TabletPSNebb02ba7-de81-4367-8ba7-d774816f85b012
1495309Timothy grass pollen extract 2800 BAU Sublingual TabletPSNebb02ba7-de81-4367-8ba7-d774816f85b012
1495316Timothy grass pollen extract 2800 BAU Sublingual Tablet [Grastek]SBDebb02ba7-de81-4367-8ba7-d774816f85b012
1495309Timothy grass pollen extract 2800 BAU Sublingual TabletSCDebb02ba7-de81-4367-8ba7-d774816f85b012
1495316Grastek 2800 BAU Sublingual TabletSYebb02ba7-de81-4367-8ba7-d774816f85b012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52709-1501-15270915010110 in 1 BLISTER PACKHistorical
52709-1501-3527091501033 BLISTER PACK in 1 CARTON (52709-1501-3) / 10 TABLET in 1 BLISTER PACK (52709-1501-1) 3 blister pack2014-04-110000-00-00NoNoCurrent
52709-1501-5527091501051 BLISTER PACK in 1 CARTON (52709-1501-5) / 5 TABLET in 1 BLISTER PACK1 blister pack2014-04-110000-00-00NoNoCurrent