NDC 36987-2021

Nigrospora sphaerica

Nigrospora Sphaerica

Nigrospora sphaerica is a Intradermal; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Nelco Laboratories, Inc.. The primary component is Khuskia Oryzae.

• Product ID: 36987-2021_e1e95062-bc51-41aa-9192-7fcbf93be13a
• NDC: 36987-2021
• Product Type: Human Prescription Drug
• Proprietary Name: Nigrospora sphaerica
• Generic Name: Nigrospora Sphaerica
• Dosage Form: Injection, Solution
• Route of Administration: INTRADERMAL; SUBCUTANEOUS
• Marketing Start Date: 1972-08-29
• Marketing Category: BLA / BLA
• Application Number: BLA102192
• Labeler Name: Nelco Laboratories, Inc.
• Substance Name: KHUSKIA ORYZAE
• Active Ingredient Strength: 20000 [PNU]/mL
• Pharm Classes: Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 36987-2021-3

30 mL in 1 VIAL, MULTI-DOSE (36987-2021-3)

• Marketing Start Date: 1972-08-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 36987-2021-1 [36987202101]

Nigrospora sphaerica INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102192
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1972-08-29
• Inactivation Date: 2019-10-21

NDC 36987-2021-3 [36987202103]

Nigrospora sphaerica INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102192
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1972-08-29
• Inactivation Date: 2019-10-21

NDC 36987-2021-2 [36987202102]

Nigrospora sphaerica INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102192
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1972-08-29
• Inactivation Date: 2019-10-21

NDC 36987-2021-4 [36987202104]

Nigrospora sphaerica INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA102192
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1972-08-29
• Inactivation Date: 2019-10-21

Drug Details

Active Ingredients

Ingredient	Strength
KHUSKIA ORYZAE	20000 [PNU]/mL

OpenFDA Data

• SPL SET ID: 6a449cfe-1838-4928-b95e-dd49cb3162b7
• Manufacturer:
  • Nelco Laboratories, Inc.
• UNII:
  • VK8C112WTS
• RxNorm Concept Unique ID - RxCUI:
  • 892481

Pharmacological Class

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

NDC Crossover Matching brand name "Nigrospora sphaerica" or generic name "Nigrospora Sphaerica"

NDC	Brand Name	Generic Name
36987-2019	Nigrospora sphaerica	Nigrospora sphaerica
36987-2020	Nigrospora sphaerica	Nigrospora sphaerica
36987-2021	Nigrospora sphaerica	Nigrospora sphaerica
36987-2022	Nigrospora sphaerica	Nigrospora sphaerica
36987-2023	Nigrospora sphaerica	Nigrospora sphaerica
36987-2024	Nigrospora sphaerica	Nigrospora sphaerica
36987-2025	Nigrospora sphaerica	Nigrospora sphaerica
36987-2026	Nigrospora sphaerica	Nigrospora shaerica
36987-2027	Nigrospora sphaerica	Nigrospora sphaerica
54575-212	NIGROSPORA SPHAERICA	khuskia oryzae