NDC 0268-8012

6 GRASS MIX

Agrostis Gigantea Pollen, Dactylis Glomerata, Festuca Pratensis, Lolium Perenne, Phleum Pratense, Poa Pratensis

6 GRASS MIX is a Subcutaneous Injection, Solution in the Non-standardized Allergenic category. It is labeled and distributed by Alk-abello, Inc.. The primary component is Phleum Pratense; Dactylis Glomerata; Poa Pratensis; Agrostis Gigantea Pollen; Festuca Pratensis; Lolium Perenne.

Product ID0268-8012_f3eb7e34-520b-49b3-a60f-3cd9cc08ae0d
NDC0268-8012
Product TypeNon-standardized Allergenic
Proprietary Name6 GRASS MIX
Generic NameAgrostis Gigantea Pollen, Dactylis Glomerata, Festuca Pratensis, Lolium Perenne, Phleum Pratense, Poa Pratensis
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date1975-01-15
Marketing CategoryBLA / BLA
Application NumberBLA103753
Labeler NameALK-Abello, Inc.
Substance NamePHLEUM PRATENSE; DACTYLIS GLOMERATA; POA PRATENSIS; AGROSTIS GIGANTEA POLLEN; FESTUCA PRATENSIS; LOLIUM PERENNE
Active Ingredient Strength20000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL
Pharm ClassesStandardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0268-8012-30

32 mL in 1 VIAL (0268-8012-30)
Marketing Start Date1975-01-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0268-8012-30 [00268801230]

6 GRASS MIX INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103753
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1975-01-15

Drug Details

Active Ingredients

IngredientStrength
PHLEUM PRATENSE20000 [PNU]/mL

Pharmacological Class

  • Standardized Pollen Allergenic Extract [EPC]
  • Non-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 "6 GRASS MIX" or generic name "Agrostis Gigantea Pollen, Dactylis Glomerata, Festuca Pratensis, Lolium Perenne, Phleum Pratense, Poa Pratensis"

NDCBrand NameGeneric Name
0268-80116 GRASS MIXAGROSTIS GIGANTEA POLLEN, DACTYLIS GLOMERATA, FESTUCA PRATENSIS, LOLIUM PERENNE, PHLEUM PRATENSE, POA PRATENSIS
0268-80126 GRASS MIXAGROSTIS GIGANTEA POLLEN, DACTYLIS GLOMERATA, FESTUCA PRATENSIS, LOLIUM PERENNE, PHLEUM PRATENSE, POA PRATENSIS

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