NDC 0268-8017

9 SOUTHERN GRASS MIX

Agrostis Gigantea Pollen, Anthoxanthum Odoratum, Cynodon Dactylon, Dactylis Glomerata, Festuca Pratensis, Lolium Perenne, Phleum Pratense, Poa Pratensis, Sorghum Halepense Pollen

9 SOUTHERN 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 Cynodon Dactylon; Sorghum Halepense Pollen; Phleum Pratense; Dactylis Glomerata; Poa Pratensis; Agrostis Gigantea Pollen; Festuca Pratensis; Lolium Perenne; Anthoxanthum Odoratum.

• Product ID: 0268-8017_f3eb7e34-520b-49b3-a60f-3cd9cc08ae0d
• NDC: 0268-8017
• Product Type: Non-standardized Allergenic
• Proprietary Name: 9 SOUTHERN GRASS MIX
• Generic Name: Agrostis Gigantea Pollen, Anthoxanthum Odoratum, Cynodon Dactylon, Dactylis Glomerata, Festuca Pratensis, Lolium Perenne, Phleum Pratense, Poa Pratensis, Sorghum Halepense Pollen
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 1975-01-15
• Marketing Category: BLA / BLA
• Application Number: BLA103753
• Labeler Name: ALK-Abello, Inc.
• Substance Name: CYNODON DACTYLON; SORGHUM HALEPENSE POLLEN; PHLEUM PRATENSE; DACTYLIS GLOMERATA; POA PRATENSIS; AGROSTIS GIGANTEA POLLEN; FESTUCA PRATENSIS; LOLIUM PERENNE; ANTHOXANTHUM ODORATUM
• Active Ingredient Strength: 10000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL
• Pharm Classes: Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],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 Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0268-8017-30

32 mL in 1 VIAL (0268-8017-30)

• Marketing Start Date: 1975-01-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0268-8017-30 [00268801730]

9 SOUTHERN GRASS MIX INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103753
• Product Type: NON-STANDARDIZED ALLERGENIC
• Marketing Start Date: 1975-01-15

Drug Details

Active Ingredients

Ingredient	Strength
CYNODON DACTYLON	10000 [PNU]/mL

Pharmacological Class

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