NDC 49288-0473

Sole

Sole

Sole 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 English Sole.

• Product ID: 49288-0473_38eb8027-2cc3-42f8-ad39-70588a8bd791
• NDC: 49288-0473
• Product Type: Human Prescription Drug
• Proprietary Name: Sole
• Generic Name: Sole
• Dosage Form: Injection, Solution
• Route of Administration: INTRADERMAL; SUBCUTANEOUS
• Marketing Start Date: 1974-03-23
• Marketing Category: BLA / BLA
• Application Number: BLA102223
• Labeler Name: Antigen Laboratories, Inc.
• Substance Name: ENGLISH SOLE
• Active Ingredient Strength: 0 g/mL
• Pharm Classes: Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Fish Proteins, Dietary [EXT]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 49288-0473-4

30 mL in 1 VIAL, MULTI-DOSE (49288-0473-4)

• Marketing Start Date: 1974-03-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49288-0473-4 [49288047304]

Sole INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102223
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1974-03-23
• Inactivation Date: 2019-10-21

NDC 49288-0473-1 [49288047301]

Sole INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102223
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1974-03-23
• Inactivation Date: 2019-10-21

NDC 49288-0473-3 [49288047303]

Sole INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102223
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1974-03-23
• Inactivation Date: 2019-10-21

NDC 49288-0473-2 [49288047302]

Sole INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102223
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1974-03-23
• Inactivation Date: 2019-10-21

NDC 49288-0473-5 [49288047305]

Sole INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102223
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1974-03-23
• Inactivation Date: 2019-10-21

Drug Details

Active Ingredients

Ingredient	Strength
ENGLISH SOLE	.05 g/mL

OpenFDA Data

• SPL SET ID: 5a47186d-964b-42e2-bc55-c18cd6fbc08f
• Manufacturer:
  • Antigen Laboratories, Inc.
• UNII:
  • 00CR8124AS
• RxNorm Concept Unique ID - RxCUI:
  • 968433

Pharmacological Class

• Non-Standardized Food Allergenic Extract [EPC]
• Increased Histamine Release [PE]
• Cell-mediated Immunity [PE]
• Allergens [CS]
• Dietary Proteins [CS]
• Fish Proteins
• Dietary [EXT]