NDC 0268-8009

5 GRASS MIX

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

5 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; Anthoxanthum Odoratum.

• Product ID: 0268-8009_f3eb7e34-520b-49b3-a60f-3cd9cc08ae0d
• NDC: 0268-8009
• Product Type: Non-standardized Allergenic
• Proprietary Name: 5 GRASS MIX
• Generic Name: Agrostis Gigantea Pollen, Anthoxanthum Odoratum, Dactylis Glomerata, Phleum Pratense, Poa Pratensis
• 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: PHLEUM PRATENSE; DACTYLIS GLOMERATA; POA PRATENSIS; AGROSTIS GIGANTEA POLLEN; ANTHOXANTHUM ODORATUM
• Active Ingredient Strength: 20000 [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL; [PNU]/mL
• Pharm Classes: 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 0268-8009-10

10.5 mL in 1 VIAL (0268-8009-10)

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

NDC SPL Data Element Entries

NDC 0268-8009-30 [00268800930]

5 GRASS MIX INJECTION, SOLUTION

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

NDC 0268-8009-10 [00268800910]

5 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
PHLEUM PRATENSE	20000 [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 "5 GRASS MIX" or generic name "Agrostis Gigantea Pollen, Anthoxanthum Odoratum, Dactylis Glomerata, Phleum Pratense, Poa Pratensis"

NDC	Brand Name	Generic Name
0268-8005	5 GRASS MIX	PHLEUM PRATENSE POLLEN, DACTYLIS GLOMERATA POLLEN, POA PRATENSIS POLLEN, AGROSTIS GIGANTEA POLLEN, ANTHOXANTHUM ODORATUM POLLEN
0268-8006	5 GRASS MIX	PHLEUM PRATENSE POLLEN, DACTYLIS GLOMERATA POLLEN, POA PRATENSIS POLLEN, AGROSTIS GIGANTEA POLLEN, ANTHOXANTHUM ODORATUM POLLEN
0268-8007	5 GRASS MIX	PHLEUM PRATENSE POLLEN, DACTYLIS GLOMERATA POLLEN, POA PRATENSIS POLLEN, AGROSTIS GIGANTEA POLLEN, ANTHOXANTHUM ODORATUM POLLEN
0268-8008	5 GRASS MIX	AGROSTIS GIGANTEA POLLEN, ANTHOXANTHUM ODORATUM, DACTYLIS GLOMERATA, PHLEUM PRATENSE, POA PRATENSIS
0268-8009	5 GRASS MIX	AGROSTIS GIGANTEA POLLEN, ANTHOXANTHUM ODORATUM, DACTYLIS GLOMERATA, PHLEUM PRATENSE, POA PRATENSIS
0268-8010	5 GRASS MIX	PHLEUM PRATENSE POLLEN, DACTYLIS GLOMERATA POLLEN, POA PRATENSIS POLLEN, AGROSTIS GIGANTEA POLLEN, ANTHOXANTHUM ODORATUM POLLEN