NDC 0268-3064

Timothy, Standardized

Timothy, Standardized

Timothy, Standardized is a Percutaneous Solution in the Human Prescription Drug category. It is labeled and distributed by Alk-abello, Inc.. The primary component is Phleum Pratense Pollen.

Product ID0268-3064_13f1ef62-876b-4a9f-90cd-bb7e307157e9
NDC0268-3064
Product TypeHuman Prescription Drug
Proprietary NameTimothy, Standardized
Generic NameTimothy, Standardized
Dosage FormSolution
Route of AdministrationPERCUTANEOUS
Marketing Start Date1997-12-18
Marketing CategoryBLA / BLA
Application NumberBLA103058
Labeler NameALK-Abello, Inc.
Substance NamePHLEUM PRATENSE POLLEN
Active Ingredient Strength10000 [BAU]/mL
Pharm ClassesStandardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 0268-3064-06

5 mL in 1 VIAL, MULTI-DOSE (0268-3064-06)
Marketing Start Date1997-12-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0268-3064-06 [00268306406]

Timothy, Standardized SOLUTION
Marketing CategoryBLA
Application NumberBLA103058
Product TypeSTANDARDIZED ALLERGENIC
Marketing Start Date1997-12-18
Marketing End Date2019-10-17

Drug Details

Active Ingredients

IngredientStrength
PHLEUM PRATENSE POLLEN10000 [BAU]/mL

Pharmacological Class

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

NDC Crossover Matching brand name "Timothy, Standardized" or generic name "Timothy, Standardized"

NDCBrand NameGeneric Name
0268-0279Timothy, StandardizedTimothy, Standardized
0268-0280Timothy, StandardizedTimothy, Standardized
0268-3063Timothy, StandardizedTimothy, Standardized
0268-3064Timothy, StandardizedTimothy, Standardized
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