NDC 49643-343

Standardized Orchard Grass

Dactylis Glomerata

Standardized Orchard 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 Dactylis Glomerata Pollen.

• Product ID: 49643-343_92edfda3-37dd-daa1-e053-2a95a90a5c1f
• NDC: 49643-343
• Product Type: Human Prescription Drug
• Proprietary Name: Standardized Orchard Grass
• Generic Name: Dactylis Glomerata
• Dosage Form: Injection
• Route of Administration: CUTANEOUS; INTRADERMAL; SUBCUTANEOUS
• Marketing Start Date: 1996-12-02
• Marketing Category: BLA / BLA
• Application Number: BLA102217
• Labeler Name: Allermed Laboratories, Inc.
• Substance Name: DACTYLIS GLOMERATA POLLEN
• Active Ingredient Strength: 100000 [BAU]/mL
• Pharm Classes: 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 49643-343-05

5 mL in 1 VIAL, MULTI-DOSE (49643-343-05)

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

NDC SPL Data Element Entries

NDC 49643-343-05 [49643034305]

Standardized Orchard Grass INJECTION

• Marketing Category: BLA
• Application Number: BLA102217
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1996-12-02

NDC 49643-343-50 [49643034350]

Standardized Orchard Grass INJECTION

• Marketing Category: BLA
• Application Number: BLA102217
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1996-12-02

NDC 49643-343-10 [49643034310]

Standardized Orchard Grass INJECTION

• Marketing Category: BLA
• Application Number: BLA102217
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1996-12-02

NDC 49643-343-30 [49643034330]

Standardized Orchard Grass INJECTION

• Marketing Category: BLA
• Application Number: BLA102217
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1996-12-02

Drug Details

Active Ingredients

Ingredient	Strength
DACTYLIS GLOMERATA POLLEN	100000 [BAU]/mL

Pharmacological Class

• 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 Orchard Grass" or generic name "Dactylis Glomerata"

NDC	Brand Name	Generic Name
49643-343	Standardized Orchard Grass	Dactylis glomerata
22840-0205	Standardized Orchard Grass Pollen	Dactylis glomerata
22840-0206	Standardized Orchard Grass Pollen	Dactylis glomerata