NDC 36987-1966

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 ID36987-1966_a9a7717a-fa1d-462b-b0eb-5f1993dba6a3
NDC36987-1966
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 Strength10000 [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 36987-1966-1

5 mL in 1 VIAL, MULTI-DOSE (36987-1966-1)
Marketing Start Date1972-08-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36987-1966-4 [36987196604]

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

NDC 36987-1966-1 [36987196601]

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

NDC 36987-1966-2 [36987196602]

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

NDC 36987-1966-3 [36987196603]

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 NIGRUM10000 [PNU]/mL

OpenFDA Data

SPL SET ID:e464ea5b-a803-4c5a-93d2-cc3fbca8d3a8
Manufacturer
UNII
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 "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

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