NDC 49288-0174

Standardized Mite, Dermatophagoides pteronyssinus

Standardized Mite, Dermatophagoides Pteronyssinus

Standardized Mite, Dermatophagoides pteronyssinus is a Intradermal; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Antigen Laboratories, Inc.. The primary component is Dermatophagoides Pteronyssinus.

• Product ID: 49288-0174_745162a9-2fdc-4b03-a3bc-32d410b3d9c1
• NDC: 49288-0174
• Product Type: Human Prescription Drug
• Proprietary Name: Standardized Mite, Dermatophagoides pteronyssinus
• Generic Name: Standardized Mite, Dermatophagoides Pteronyssinus
• Dosage Form: Injection, Solution
• Route of Administration: INTRADERMAL; SUBCUTANEOUS
• Marketing Start Date: 1991-10-22
• Marketing Category: BLA / BLA
• Application Number: BLA102225
• Labeler Name: Antigen Laboratories, 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: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 49288-0174-3

10 mL in 1 VIAL, MULTI-DOSE (49288-0174-3)

• Marketing Start Date: 1991-10-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49288-0174-3 [49288017403]

Standardized Mite, Dermatophagoides pteronyssinus INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102225
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1991-10-22
• Inactivation Date: 2019-10-21

NDC 49288-0174-5 [49288017405]

Standardized Mite, Dermatophagoides pteronyssinus INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102225
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1991-10-22
• Inactivation Date: 2019-10-21

NDC 49288-0174-4 [49288017404]

Standardized Mite, Dermatophagoides pteronyssinus INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102225
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1991-10-22
• Inactivation Date: 2019-10-21

Drug Details

Active Ingredients

Ingredient	Strength
DERMATOPHAGOIDES PTERONYSSINUS	5000 [AU]/mL

OpenFDA Data

• SPL SET ID: 3b3cb12c-65d3-46ab-9bac-82c569a76220
• Manufacturer:
  • Antigen Laboratories, Inc.
• UNII:
  • 57L1Z5378K
  • PR9U2YPF3Q
• RxNorm Concept Unique ID - RxCUI:
  • 852813
  • 1192787
  • 1014382
  • 1014384
  • 852825
  • 1014369
  • 852829

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, Dermatophagoides pteronyssinus" or generic name "Standardized Mite, Dermatophagoides Pteronyssinus"

NDC	Brand Name	Generic Name
49288-0172	Standardized Mite, Dermatophagoides pteronyssinus	Standardized Mite, Dermatophagoides pteronyssinus
49288-0173	Standardized Mite, Dermatophagoides pteronyssinus	Standardized Mite, Dermatophagoides pteronyssinus
49288-0174	Standardized Mite, Dermatophagoides pteronyssinus	Standardized Mite, Dermatophagoides pteronyssinus