NDC 49643-309

Standardized Redtop Grass

Agrostis Alba

Standardized Redtop Grass is a Cutaneous; Intradermal; Subcutaneous Injection in the Human Prescription Drug category. It is labeled and distributed by Allermed Laboratories, Inc.. The primary component is Agrostis Gigantea Pollen.

• Product ID: 49643-309_92edfda3-37dd-daa1-e053-2a95a90a5c1f
• NDC: 49643-309
• Product Type: Human Prescription Drug
• Proprietary Name: Standardized Redtop Grass
• Generic Name: Agrostis Alba
• Dosage Form: Injection
• Route of Administration: CUTANEOUS; INTRADERMAL; SUBCUTANEOUS
• Marketing Start Date: 1996-12-02
• Marketing Category: BLA / BLA
• Application Number: BLA102218
• Labeler Name: Allermed Laboratories, Inc.
• Substance Name: AGROSTIS GIGANTEA POLLEN
• Active Ingredient Strength: 100000 [BAU]/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: 2020-12-31

Packaging

NDC 49643-309-05

5 mL in 1 VIAL, MULTI-DOSE (49643-309-05)

• Marketing Start Date: 1996-12-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49643-309-50 [49643030950]

Standardized Redtop Grass INJECTION

• Marketing Category: BLA
• Application Number: BLA102218
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1996-12-02

NDC 49643-309-30 [49643030930]

Standardized Redtop Grass INJECTION

• Marketing Category: BLA
• Application Number: BLA102218
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1996-12-02

NDC 49643-309-10 [49643030910]

Standardized Redtop Grass INJECTION

• Marketing Category: BLA
• Application Number: BLA102218
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1996-12-02

NDC 49643-309-05 [49643030905]

Standardized Redtop Grass INJECTION

• Marketing Category: BLA
• Application Number: BLA102218
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1996-12-02

Drug Details

Active Ingredients

Ingredient	Strength
AGROSTIS GIGANTEA POLLEN	100000 [BAU]/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 "Standardized Redtop Grass" or generic name "Agrostis Alba"

NDC	Brand Name	Generic Name
49643-309	Standardized Redtop Grass	Agrostis alba
22840-0207	Standardized Redtop Pollen	Agrostis alba
22840-0208	Standardized Redtop Pollen	Agrostis alba