NDC 36987-2075

Rhizopus oryzae

Rhizopus Oryzae

Rhizopus oryzae 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 Rhizopus Arrhizus Var. Arrhizus.

• Product ID: 36987-2075_0dbb0652-e487-4678-a747-b379f75821dc
• NDC: 36987-2075
• Product Type: Human Prescription Drug
• Proprietary Name: Rhizopus oryzae
• Generic Name: Rhizopus Oryzae
• 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: RHIZOPUS ARRHIZUS VAR. ARRHIZUS
• 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 [Chemical/Ingredient],Allergens [Chemical/Ingredient]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 36987-2075-1

5 mL in 1 VIAL, MULTI-DOSE (36987-2075-1)

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

NDC SPL Data Element Entries

NDC 36987-2075-2 [36987207502]

Rhizopus oryzae 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 36987-2075-3 [36987207503]

Rhizopus oryzae 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 36987-2075-1 [36987207501]

Rhizopus oryzae 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 36987-2075-4 [36987207504]

Rhizopus oryzae 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
RHIZOPUS ARRHIZUS VAR. ARRHIZUS	20000 [PNU]/mL

OpenFDA Data

• SPL SET ID: 102d5d44-e217-4e5d-a9ac-a242388a5cc9
• Manufacturer:
  • Nelco Laboratories, Inc.
• UNII:
  • 3F36V0451W
  • D1A2NG69CK
  • 2072U60DUI
  • 62TY3X4N9Z
  • 3Y1PE1GCIG
  • TGO054E31O
  • 4K7Z7K7SWG
  • V4OQR60A5P
  • UPX000VMIF
  • TBW53313S7
  • C7000B9PQI
  • BV82OL2IZ8
  • 978D8U419H
  • 3LN5B70U4W
  • QBN8K7055X
  • O0HJ02QBWN
  • 87U156LEN7
  • 49W168AES4
  • X88DF51T48
  • 199I7J3JIV
  • 5016WB8B8A
  • CA33Q4013Q
  • 5964J742O8
  • 3J888Y9L13
  • 4ZWY20GTGO
  • 8476849N1Y
  • 9IOA40ANG6
  • 52B29REC7H
  • XQ14H1462M
  • YIH315U1TU
  • W042YAB8JC
  • 4D7G21HDBC
  • D7401PWY6E
• RxNorm Concept Unique ID - RxCUI:
  • 889579
  • 999456
  • 968484
  • 967953
  • 967904
  • 967543
  • 889538
  • 1000163
  • 999432
  • 999513
  • 999492
  • 968534
  • 999498
  • 968456
  • 968149
  • 999449
  • 966954
  • 999402
  • 999443
  • 999468
  • 999462
  • 1006335
  • 905079
  • 999425
  • 999427
  • 999393
  • 999503
  • 968400
  • 966689
  • 966666
  • 967045
  • 967057
  • 889611
• Pharm Class PE:
  • Cell-mediated Immunity [PE]
  • Increased IgG Production [PE]
  • Increased Histamine Release [PE]
• PHarm Class EPC:
  • Non-Standardized Fungal Allergenic Extract [EPC]
• NUI Code:
  • N0000185001
  • N0000175629
  • N0000171131
  • N0000185372
  • N0000169106
  • N0000184306

Pharmacological Class

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

NDC Crossover Matching brand name "Rhizopus oryzae" or generic name "Rhizopus Oryzae"

NDC	Brand Name	Generic Name
22840-2619	Rhizopus oryzae	Rhizopus oryzae
22840-2620	Rhizopus oryzae	Rhizopus oryzae
22840-2621	Rhizopus oryzae	Rhizopus oryzae
22840-5633	Rhizopus oryzae	Rhizopus oryzae
36987-2073	Rhizopus oryzae	Rhizopus oryzae
36987-2074	Rhizopus oryzae	Rhizopus oryzae
36987-2075	Rhizopus oryzae	Rhizopus oryzae
36987-2076	Rhizopus oryzae	Rhizopus oryzae
36987-2077	Rhizopus oryzae	Rhizopus oryzae
36987-2078	Rhizopus oryzae	Rhizopus oryzae
36987-2079	Rhizopus oryzae	Rhizopus oryzae
36987-2080	Rhizopus oryzae	Rhizopus oryzae
36987-2081	Rhizopus oryzae	Rhizopus oryzae
49643-118	Rhizopus	Rhizopus oryzae