NDC 36987-2065

Aureobasidium pullulans

Aureobasidium Pullulans

Aureobasidium pullulans 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 Aureobasidium Pullulans Var. Pullutans.

• Product ID: 36987-2065_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3
• NDC: 36987-2065
• Product Type: Human Prescription Drug
• Proprietary Name: Aureobasidium pullulans
• Generic Name: Aureobasidium Pullulans
• 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: AUREOBASIDIUM PULLULANS VAR. PULLUTANS
• Active Ingredient Strength: 10000 [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 36987-2065-2

10 mL in 1 VIAL, MULTI-DOSE (36987-2065-2)

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

NDC SPL Data Element Entries

NDC 36987-2065-3 [36987206503]

Aureobasidium pullulans 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 36987-2065-2 [36987206502]

Aureobasidium pullulans 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 36987-2065-1 [36987206501]

Aureobasidium pullulans 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 36987-2065-4 [36987206504]

Aureobasidium pullulans 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
AUREOBASIDIUM PULLULANS VAR. PULLUTANS	10000 [PNU]/mL

OpenFDA Data

• SPL SET ID: e464ea5b-a803-4c5a-93d2-cc3fbca8d3a8
• 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:
  • 999447
  • 967872
  • 967951
  • 999453
  • 999418
  • 967541
  • 999387
  • 889618
  • 307937
  • 999430
  • 999490
  • 867153
  • 999511
  • 999466
  • 968452
  • 968146
  • 1006333
  • 967041
  • 999460
  • 966952
  • 999400
  • 867175
  • 999441
  • 889540
  • 968482
  • 905077
  • 968350
  • 999501
  • 966687
  • 889585
  • 902638
  • 867181
  • 967055
• 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 [CS]
• Allergens [CS]

NDC Crossover Matching brand name "Aureobasidium pullulans" or generic name "Aureobasidium Pullulans"

NDC	Brand Name	Generic Name
0268-8086	AUREOBASIDIUM PULLULANS	AUREOBASIDIUM PULLULANS VAR. PULLUTANS
0268-8087	AUREOBASIDIUM PULLULANS	AUREOBASIDIUM PULLULANS VAR. PULLUTANS
22840-1630	Aureobasidium pullulans	Aureobasidium pullulans
22840-5607	Aureobasidium pullulans	Aureobasidium pullulans
36987-2064	Aureobasidium pullulans	Aureobasidium pullulans
36987-2065	Aureobasidium pullulans	Aureobasidium pullulans
36987-2066	Aureobasidium pullulans	Aureobasidium pullulans
36987-2067	Aureobasidium pullulans	Aureobasidium pullulans
36987-2068	Aureobasidium pullulans	Aureobasidium pullulans
36987-2069	Aureobasidium pullulans	Aureobasidium pullulans
36987-2070	Aureobasidium pullulans	Aureobasidium pullulans
36987-2071	Aureobasidium pullulans	Aureobasidium pullulans
36987-2072	Aureobasidium pullulans	Aureobasidium pullulans