NDC 0268-0278

Standardized Mite D. pteronyssinus

Standardized Mite D. Pteronyssinus

Standardized Mite D. pteronyssinus is a Subcutaneous Injection, Solution in the Standardized Allergenic category. It is labeled and distributed by Alk-abello, Inc.. The primary component is Dermatophagoides Pteronyssinus.

• Product ID: 0268-0278_64709142-a40b-4ce8-8bb9-02459e658b05
• NDC: 0268-0278
• Product Type: Standardized Allergenic
• Proprietary Name: Standardized Mite D. pteronyssinus
• Generic Name: Standardized Mite D. Pteronyssinus
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 1990-08-14
• Marketing Category: BLA / BLA
• Application Number: BLA103752
• Labeler Name: ALK-Abello, Inc.
• Substance Name: DERMATOPHAGOIDES PTERONYSSINUS
• Active Ingredient Strength: 5000 [AU]/mL
• Pharm Classes: Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS],Insect Proteins [CS],Allergens [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0268-0278-10

10 mL in 1 VIAL, MULTI-DOSE (0268-0278-10)

• Marketing Start Date: 1990-08-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0268-0278-30 [00268027830]

Standardized Mite D. pteronyssinus INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103752
• Product Type: STANDARDIZED ALLERGENIC
• Marketing Start Date: 1990-08-14

NDC 0268-0278-10 [00268027810]

Standardized Mite D. pteronyssinus INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103752
• Product Type: STANDARDIZED ALLERGENIC
• Marketing Start Date: 1990-08-14

NDC 0268-0278-50 [00268027850]

Standardized Mite D. pteronyssinus INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103752
• Product Type: STANDARDIZED ALLERGENIC
• Marketing Start Date: 1990-08-14

Drug Details

Active Ingredients

Ingredient	Strength
DERMATOPHAGOIDES PTERONYSSINUS	5000 [AU]/mL

Pharmacological Class

• Standardized Insect Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Antigens
• Dermatophagoides [CS]
• Insect Proteins [CS]
• Allergens [CS]

NDC Crossover Matching brand name "Standardized Mite D. pteronyssinus" or generic name "Standardized Mite D. Pteronyssinus"

NDC	Brand Name	Generic Name
0268-0277	Standardized Mite D. pteronyssinus	Standardized Mite D. pteronyssinus
0268-0278	Standardized Mite D. pteronyssinus	Standardized Mite D. pteronyssinus
0268-7001	Standardized Mite D. pteronyssinus	Standardized Mite D. pteronyssinus