NDC 49643-342

Standardized Bermuda Grass

Cynodon Dactylon

Standardized Bermuda 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 Cynodon Dactylon Pollen.

• Product ID: 49643-342_92edfda3-37dd-daa1-e053-2a95a90a5c1f
• NDC: 49643-342
• Product Type: Human Prescription Drug
• Proprietary Name: Standardized Bermuda Grass
• Generic Name: Cynodon Dactylon
• Dosage Form: Injection
• Route of Administration: CUTANEOUS; INTRADERMAL; SUBCUTANEOUS
• Marketing Start Date: 1996-12-02
• Marketing Category: BLA / BLA
• Application Number: BLA102214
• Labeler Name: Allermed Laboratories, Inc.
• Substance Name: CYNODON DACTYLON POLLEN
• Active Ingredient Strength: 10000 [BAU]/mL
• Pharm Classes: Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 49643-342-05

5 mL in 1 VIAL, MULTI-DOSE (49643-342-05)

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

NDC SPL Data Element Entries

NDC 49643-342-30 [49643034230]

Standardized Bermuda Grass INJECTION

• Marketing Category: BLA
• Application Number: BLA102214
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1996-12-02

NDC 49643-342-50 [49643034250]

Standardized Bermuda Grass INJECTION

• Marketing Category: BLA
• Application Number: BLA102214
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1996-12-02

NDC 49643-342-05 [49643034205]

Standardized Bermuda Grass INJECTION

• Marketing Category: BLA
• Application Number: BLA102214
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1996-12-02

NDC 49643-342-10 [49643034210]

Standardized Bermuda Grass INJECTION

• Marketing Category: BLA
• Application Number: BLA102214
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1996-12-02

Drug Details

Active Ingredients

Ingredient	Strength
CYNODON DACTYLON POLLEN	10000 [BAU]/mL

Pharmacological Class

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

NDC Crossover Matching brand name "Standardized Bermuda Grass" or generic name "Cynodon Dactylon"

NDC	Brand Name	Generic Name
49643-342	Standardized Bermuda Grass	Cynodon dactylon
22840-0200	Standardized Bermuda Grass Pollen	Cynodon dactylon