NDC Code(s) : 0006-4229-01, 0006-4229-30, 0006-4229-02
Packager : Merck Sharp & Dohme Corp.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

GRASTEKTimothy Grass Pollen Allergen Extract TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0006-4229
Route of Administration SUBLINGUAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHLEUM PRATENSE POLLEN(UNII: 65M88RW2EG)
(PHLEUM PRATENSE POLLEN - UNII:65M88RW2EG) 		PHLEUM PRATENSE POLLEN2800 [BAU]
Inactive Ingredients
Ingredient Name Strength
MARINE COLLAGEN, SOLUBLE(UNII: 8JC99XGU4W)
MANNITOL(UNII: 3OWL53L36A)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND Size 13 mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0006-4229-303 in 1 CARTON
1NDC:0006-4229-0110 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:0006-4229-021 in 1 CARTON
25 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125473 04/11/2014

PRINCIPAL DISPLAY PANEL

NDC 0006-4229-30
This carton contains 30 sublingual tablets in three 10-Tablet blister cards

Timothy Grass Pollen Allergen Extract,
Grastek® Tablet for sublingual use

2800 BAU

For Adults and Children 5 to 65 Years of Age
Each Grastek tablet contains 2800 Bioequivalent Allergy Units (BAUs) of timothy grass pollen
allergen extract.
Dispense the enclosed Medication Guide to the patient.
Keep this and all drugs out of the reach of children.

Rx only

PRINCIPAL DISPLAY PANEL - 2800 BAU Tablet Blister Pack Carton