NDC 52709-1501

GRASTEK

Timothy Grass Pollen Allergen Extract

GRASTEK is a Sublingual Tablet in the Standardized Allergenic category. It is labeled and distributed by Alk-abell. The primary component is Phleum Pratense Pollen.

• Product ID: 52709-1501_13563f37-d368-48f8-8d55-a657b6b6ff15
• NDC: 52709-1501
• Product Type: Standardized Allergenic
• Proprietary Name: GRASTEK
• Generic Name: Timothy Grass Pollen Allergen Extract
• Dosage Form: Tablet
• Route of Administration: SUBLINGUAL
• Marketing Start Date: 2014-04-11
• Marketing Category: BLA / BLA
• Application Number: BLA125473
• Labeler Name: ALK-Abell
• Substance Name: PHLEUM PRATENSE POLLEN
• Active Ingredient Strength: 2800 [BAU]/1
• Pharm Classes: Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 52709-1501-3

3 BLISTER PACK in 1 CARTON (52709-1501-3) > 10 TABLET in 1 BLISTER PACK (52709-1501-1)

• Marketing Start Date: 2014-04-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52709-1501-3 [52709150103]

GRASTEK TABLET

• Marketing Category: BLA
• Application Number: BLA125473
• Product Type: STANDARDIZED ALLERGENIC
• Billing Unit: EA
• Marketing Start Date: 2014-04-11

NDC 52709-1501-1 [52709150101]

GRASTEK TABLET

• Marketing Category: BLA
• Application Number: BLA125473
• Product Type: STANDARDIZED ALLERGENIC
• Billing Unit: EA
• Marketing Start Date: 2014-04-11

NDC 52709-1501-5 [52709150105]

GRASTEK TABLET

• Marketing Category: BLA
• Application Number: BLA125473
• Product Type: STANDARDIZED ALLERGENIC
• Marketing Start Date: 2014-04-11

Drug Details

Active Ingredients

Ingredient	Strength
PHLEUM PRATENSE POLLEN	2800 [BAU]/1

Pharmacological Class

• Standardized Pollen Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Pollen [CS]
• Allergens [CS]