NDC 0268-8016

8 SOUTHERN GRASS MIX

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

8 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.

• Product ID: 0268-8016_f3eb7e34-520b-49b3-a60f-3cd9cc08ae0d
• NDC: 0268-8016
• Product Type: Non-standardized Allergenic
• Proprietary Name: 8 SOUTHERN GRASS MIX
• Generic Name: Agrostis Gigantea Pollen, 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
• Active Ingredient Strength: 20000 [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 0268-8016-30

32 mL in 1 VIAL (0268-8016-30)

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

NDC SPL Data Element Entries

NDC 0268-8016-30 [00268801630]

8 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	20000 [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]

NDC Crossover Matching brand name "8 SOUTHERN GRASS MIX" or generic name "Agrostis Gigantea Pollen, Cynodon Dactylon, Dactylis Glomerata, Festuca Pratensis, Lolium Perenne, Phleum Pratense, Poa Pratensis, Sorghum Halepense Pollen"

NDC	Brand Name	Generic Name
0268-8015	8 SOUTHERN GRASS MIX	AGROSTIS GIGANTEA POLLEN, CYNODON DACTYLON, DACTYLIS GLOMERATA, FESTUCA PRATENSIS, LOLIUM PERENNE, PHLEUM PRATENSE, POA PRATENSIS, SORGHUM HALEPENSE POLLEN
0268-8016	8 SOUTHERN GRASS MIX	AGROSTIS GIGANTEA POLLEN, CYNODON DACTYLON, DACTYLIS GLOMERATA, FESTUCA PRATENSIS, LOLIUM PERENNE, PHLEUM PRATENSE, POA PRATENSIS, SORGHUM HALEPENSE POLLEN