NDC 0268-6508

ASPERGILLUS NIGER VAR NIGER

Aspergillus Niger

ASPERGILLUS NIGER VAR NIGER is a Intradermal Injection, Solution in the Non-standardized Allergenic category. It is labeled and distributed by Alk-abello, Inc.. The primary component is Aspergillus Niger Var. Niger.

Product ID0268-6508_06c812ac-2bfd-444c-b2b9-50076167486c
NDC0268-6508
Product TypeNon-standardized Allergenic
Proprietary NameASPERGILLUS NIGER VAR NIGER
Generic NameAspergillus Niger
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL
Marketing Start Date1965-01-01
Marketing CategoryBLA / BLA
Application NumberBLA103753
Labeler NameALK-Abello, Inc.
Substance NameASPERGILLUS NIGER VAR. NIGER
Active Ingredient Strength1000 [PNU]/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 0268-6508-05

5 mL in 1 VIAL, MULTI-DOSE (0268-6508-05)
Marketing Start Date1965-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0268-6508-05 [00268650805]

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

Drug Details

Active Ingredients

IngredientStrength
ASPERGILLUS NIGER VAR. NIGER1000 [PNU]/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 "ASPERGILLUS NIGER VAR NIGER" or generic name "Aspergillus Niger"

NDCBrand NameGeneric Name
0268-0827ASPERGILLUS NIGER VAR NIGERASPERGILLUS NIGER
0268-0828ASPERGILLUS NIGER VAR NIGERASPERGILLUS NIGER
0268-0829ASPERGILLUS NIGER VAR NIGERASPERGILLUS NIGER
0268-0830ASPERGILLUS NIGER VAR NIGERASPERGILLUS NIGER
0268-6507ASPERGILLUS NIGER VAR NIGERAspergillus Niger
0268-6508ASPERGILLUS NIGER VAR NIGERAspergillus Niger
22840-1625Aspergillus nigerAspergillus niger
22840-1626Aspergillus nigerAspergillus niger
22840-1627Aspergillus nigerAspergillus niger
22840-1628Aspergillus nigerAspergillus niger
22840-5606Aspergillus nigerAspergillus niger

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