NDC 36987-1967

Epicoccum nigrum

Epicoccum Nigrum

Epicoccum nigrum 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 Epicoccum Nigrum.

Product ID36987-1967_0dbb0652-e487-4678-a747-b379f75821dc
NDC36987-1967
Product TypeHuman Prescription Drug
Proprietary NameEpicoccum nigrum
Generic NameEpicoccum Nigrum
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1972-08-29
Marketing CategoryBLA / BLA
Application NumberBLA102192
Labeler NameNelco Laboratories, Inc.
Substance NameEPICOCCUM NIGRUM
Active Ingredient Strength20000 [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 FlagE
Listing Certified Through2017-12-31

Packaging

NDC 36987-1967-3

30 mL in 1 VIAL, MULTI-DOSE (36987-1967-3)
Marketing Start Date1972-08-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36987-1967-2 [36987196702]

Epicoccum nigrum INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102192
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1972-08-29
Inactivation Date2019-10-21

NDC 36987-1967-1 [36987196701]

Epicoccum nigrum INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102192
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1972-08-29
Inactivation Date2019-10-21

NDC 36987-1967-3 [36987196703]

Epicoccum nigrum INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102192
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1972-08-29
Inactivation Date2019-10-21

NDC 36987-1967-4 [36987196704]

Epicoccum nigrum INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102192
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1972-08-29
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
EPICOCCUM NIGRUM20000 [PNU]/mL

OpenFDA Data

SPL SET ID:102d5d44-e217-4e5d-a9ac-a242388a5cc9
Manufacturer
UNII
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 [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.