NDC 0268-7002

Standardized Mite, Mixed

Standardized Mite, Mixed

Standardized Mite, Mixed is a Subcutaneous 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: 0268-7002_0d272bb1-4853-4bef-a694-5aef113225e6
• NDC: 0268-7002
• Product Type: Standardized Allergenic
• Proprietary Name: Standardized Mite, Mixed
• Generic Name: Standardized Mite, Mixed
• Dosage Form: Injection, Solution
• Route of Administration: SUBCUTANEOUS
• 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: 10000 [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: 2021-12-31

Packaging

NDC 0268-7002-10

10 mL in 1 VIAL (0268-7002-10)

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

NDC SPL Data Element Entries

NDC 0268-7002-30 [00268700230]

Standardized Mite, Mixed INJECTION, SOLUTION

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

NDC 0268-7002-10 [00268700210]

Standardized Mite, Mixed INJECTION, SOLUTION

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

NDC 0268-7002-50 [00268700250]

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	10000 [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 "Standardized Mite, Mixed"

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