NDC 0268-6509

AUREOBASIDIUM PULLULANS VAR PULLULANS

Pullularia Pullulans

AUREOBASIDIUM PULLULANS VAR PULLULANS is a Percutaneous Injection, Solution in the Non-standardized Allergenic category. It is labeled and distributed by Alk-abello, Inc.. The primary component is Aureobasidium Pullulans Var. Pullutans.

Product ID0268-6509_06c812ac-2bfd-444c-b2b9-50076167486c
NDC0268-6509
Product TypeNon-standardized Allergenic
Proprietary NameAUREOBASIDIUM PULLULANS VAR PULLULANS
Generic NamePullularia Pullulans
Dosage FormInjection, Solution
Route of AdministrationPERCUTANEOUS
Marketing Start Date1965-01-01
Marketing CategoryBLA / BLA
Application NumberBLA103753
Labeler NameALK-Abello, Inc.
Substance NameAUREOBASIDIUM PULLULANS VAR. PULLUTANS
Active Ingredient Strength0 g/mL
Pharm ClassesNon-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0268-6509-06

5 mL in 1 VIAL, MULTI-DOSE (0268-6509-06)
Marketing Start Date1965-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0268-6509-06 [00268650906]

AUREOBASIDIUM PULLULANS VAR PULLULANS INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103753
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1965-01-01

Drug Details

Active Ingredients

IngredientStrength
AUREOBASIDIUM PULLULANS VAR. PULLUTANS.1 g/mL

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 VAR PULLULANS" or generic name "Pullularia Pullulans"

NDCBrand NameGeneric Name
0268-0832AUREOBASIDIUM PULLULANS VAR PULLULANSPULLULARIA PULLULANS
0268-0833AUREOBASIDIUM PULLULANS VAR PULLULANSPULLULARIA PULLULANS
0268-0834AUREOBASIDIUM PULLULANS VAR PULLULANSPULLULARIA PULLULANS
0268-0835AUREOBASIDIUM PULLULANS VAR PULLULANSPULLULARIA PULLULANS
0268-0836AUREOBASIDIUM PULLULANS VAR PULLULANSPULLULARIA PULLULANS
0268-6509AUREOBASIDIUM PULLULANS VAR PULLULANSPULLULARIA PULLULANS
0268-6511AUREOBASIDIUM PULLULANS VAR PULLULANSAureobasidium Pullularia Pullulans
65044-5233Molds, Rusts and Smuts, Pullularia pullulansPullularia pullulans
65044-5234Molds, Rusts and Smuts, Pullularia pullulansPullularia pullulans
65044-5235Molds, Rusts and Smuts, Pullularia pullulansPullularia pullulans
49643-117PullulariaPullularia pullulans

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.