NDC 0268-8097

EPICOCCUM NIGRUM

Epicoccum Nigrum

EPICOCCUM NIGRUM is a Percutaneous Injection, Solution in the Non-standardized Allergenic category. It is labeled and distributed by Alk-abello, Inc.. The primary component is Epicoccum Nigrum.

Product ID0268-8097_801a683a-5d7d-494b-ab42-65b57ed388c0
NDC0268-8097
Product TypeNon-standardized Allergenic
Proprietary NameEPICOCCUM NIGRUM
Generic NameEpicoccum Nigrum
Dosage FormInjection, Solution
Route of AdministrationPERCUTANEOUS
Marketing Start Date1965-01-01
Marketing CategoryBLA / BLA
Application NumberBLA103753
Labeler NameALK-Abello, Inc.
Substance NameEPICOCCUM NIGRUM
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 Through2021-12-31

Packaging

NDC 0268-8097-05

5.5 mL in 1 VIAL (0268-8097-05)
Marketing Start Date1965-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0268-8097-05 [00268809705]

EPICOCCUM NIGRUM INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103753
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1965-01-01

NDC 0268-8097-10 [00268809710]

EPICOCCUM NIGRUM INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103753
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1965-01-01

NDC 0268-8097-50 [00268809750]

EPICOCCUM NIGRUM INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103753
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1965-01-01

Drug Details

Active Ingredients

IngredientStrength
EPICOCCUM NIGRUM.05 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 "EPICOCCUM NIGRUM" or generic name "Epicoccum Nigrum"

NDCBrand NameGeneric Name
0268-0884EPICOCCUM NIGRUMEPICOCCUM NIGRUM
0268-0885EPICOCCUM NIGRUMEPICOCCUM NIGRUM
0268-0886EPICOCCUM NIGRUMEPICOCCUM NIGRUM
0268-0887EPICOCCUM NIGRUMEPICOCCUM NIGRUM
0268-0888EPICOCCUM NIGRUMEPICOCCUM NIGRUM
0268-0889EPICOCCUM NIGRUMEPICOCCUM NIGRUM
0268-0890EPICOCCUM NIGRUMEPICOCCUM NIGRUM
0268-0891EPICOCCUM NIGRUMEPICOCCUM NIGRUM
0268-0892EPICOCCUM NIGRUMEPICOCCUM NIGRUM
0268-0893EPICOCCUM NIGRUMEPICOCCUM NIGRUM
0268-6526EPICOCCUM NIGRUMEpicoccum nigrum
0268-6528EPICOCCUM NIGRUMEpicoccum nigrum
0268-8096EPICOCCUM NIGRUMEPICOCCUM NIGRUM
0268-8097EPICOCCUM NIGRUMEPICOCCUM NIGRUM
22840-1666Epicoccum nigrumEpicoccum nigrum
22840-2665Epicoccum nigrumEpicoccum nigrum
22840-5616Epicoccum nigrumEpicoccum nigrum
36987-1967Epicoccum nigrumEpicoccum nigrum
36987-1971Epicoccum nigrumEpicoccum nigrum
36987-1969Epicoccum nigrumEpicoccum nigrum
36987-1970Epicoccum nigrumEpicoccum nigrum
36987-1973Epicoccum nigrumEpicoccum nigrum
36987-1968Epicoccum nigrumEpicoccum nigrum
36987-1972Epicoccum nigrumEpicoccum nigrum
36987-1966Epicoccum nigrumEpicoccum nigrum
36987-1965Epicoccum nigrumEpicoccum nigrum
54575-194EPICOCCUM NIGRUMEPICOCCUM NIGRUM

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