NDC 0268-8014

7 GRASS MIX

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

7 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; Anthoxanthum Odoratum.

Product ID0268-8014_f3eb7e34-520b-49b3-a60f-3cd9cc08ae0d
NDC0268-8014
Product TypeNon-standardized Allergenic
Proprietary Name7 GRASS MIX
Generic NameAgrostis Gigantea Pollen, Anthoxanthum Odoratum, 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; ANTHOXANTHUM ODORATUM
Active Ingredient Strength20000 [PNU]/mL; [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 0268-8014-10

10.5 mL in 1 VIAL (0268-8014-10)
Marketing Start Date1975-01-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0268-8014-10 [00268801410]

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

NDC 0268-8014-30 [00268801430]

7 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 "7 GRASS MIX" or generic name "Agrostis Gigantea Pollen, Anthoxanthum Odoratum, Dactylis Glomerata, Festuca Pratensis, Lolium Perenne, Phleum Pratense, Poa Pratensis"

NDCBrand NameGeneric Name
0268-80137 GRASS MIXAGROSTIS GIGANTEA POLLEN, ANTHOXANTHUM ODORATUM, DACTYLIS GLOMERATA, FESTUCA PRATENSIS, LOLIUM PERENNE, PHLEUM PRATENSE, POA PRATENSIS
0268-80147 GRASS MIXAGROSTIS GIGANTEA POLLEN, ANTHOXANTHUM ODORATUM, DACTYLIS GLOMERATA, FESTUCA PRATENSIS, LOLIUM PERENNE, PHLEUM PRATENSE, POA PRATENSIS

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