NDC 0268-8116

STANDARDIZED MITE, MIXED

Dermatophagoides Farinae And Dermatophagoides Pteronyssinus

STANDARDIZED MITE, MIXED is a Percutaneous Injection, Solution in the Standardized Allergenic category. It is labeled and distributed by Alk-abello, Inc.. The primary component is Dermatophagoides Farinae; Dermatophagoides Pteronyssinus.

• Product ID: 0268-8116_03615445-db78-47fe-b504-75af3efc5dcf
• NDC: 0268-8116
• Product Type: Standardized Allergenic
• Proprietary Name: STANDARDIZED MITE, MIXED
• Generic Name: Dermatophagoides Farinae And Dermatophagoides Pteronyssinus
• Dosage Form: Injection, Solution
• Route of Administration: PERCUTANEOUS
• Marketing Start Date: 1991-07-08
• Marketing Category: BLA / BLA
• Application Number: BLA103060
• Labeler Name: ALK-Abello, Inc.
• Substance Name: DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS
• Active Ingredient Strength: 5000 [AU]/mL; [AU]/mL
• Pharm Classes: Allergens [CS],Insect Proteins [CS],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS],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: 2019-12-31

Packaging

NDC 0268-8116-06

5.5 mL in 1 VIAL (0268-8116-06)

• Marketing Start Date: 1991-07-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0268-8116-06 [00268811606]

STANDARDIZED MITE, MIXED INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA103060
• Product Type: STANDARDIZED ALLERGENIC
• Marketing Start Date: 1991-07-08

Drug Details

Active Ingredients

Ingredient	Strength
DERMATOPHAGOIDES FARINAE	5000 [AU]/mL

Pharmacological Class

• Allergens [CS]
• Insect Proteins [CS]
• Standardized Insect Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Increased IgG Production [PE]
• Antigens
• Dermatophagoides [CS]
• 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, MIXED" or generic name "Dermatophagoides Farinae And Dermatophagoides Pteronyssinus"

NDC	Brand Name	Generic Name
0268-7002	Standardized Mite, Mixed	Standardized Mite, Mixed
0268-7003	Standardized Mite, Mixed	Standardized Mite, Mixed
0268-8116	STANDARDIZED MITE, MIXED	DERMATOPHAGOIDES FARINAE and DERMATOPHAGOIDES PTERONYSSINUS
22840-0037	Standardized Mite Mix Dermatophagoides farinae and Dermatophagoides pteronyssinus	Dermatophagoides farinae and Dermatophagoides pteronyssinus
22840-0040	Standardized Mite Mix Dermatophagoides farinae and Dermatophagoides pteronyssinus	Dermatophagoides farinae and Dermatophagoides pteronyssinus