NDC 36987-1218

Halibut

Halibut

Halibut 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 Pacific Halibut.

Product ID36987-1218_7c6e2716-24f3-4479-abfc-901a69fc08d9
NDC36987-1218
Product TypeHuman Prescription Drug
Proprietary NameHalibut
Generic NameHalibut
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1972-08-29
Marketing CategoryBLA / BLA
Application NumberBLA102192
Labeler NameNelco Laboratories, Inc.
Substance NamePACIFIC HALIBUT
Active Ingredient Strength0 g/mL
Pharm ClassesNon-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Fish Proteins, Dietary [EXT]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 36987-1218-3

30 mL in 1 VIAL, MULTI-DOSE (36987-1218-3)
Marketing Start Date1972-08-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36987-1218-4 [36987121804]

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

NDC 36987-1218-1 [36987121801]

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

NDC 36987-1218-3 [36987121803]

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

NDC 36987-1218-2 [36987121802]

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

Drug Details

Active Ingredients

IngredientStrength
PACIFIC HALIBUT.05 g/mL

OpenFDA Data

SPL SET ID:26081998-16db-41f6-b366-3fd7007b99de
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 905477
  • 899749
  • 901286
  • 901377
  • 966679
  • 900034
  • 905339
  • 905335
  • 905331
  • 901268
  • 905352
  • 899431
  • 901379
  • 899437
  • 899412
  • 966976
  • 905487
  • 905482
  • 899919
  • 905363
  • 901393
  • 905327
  • Pharmacological Class

    • Non-Standardized Food Allergenic Extract [EPC]
    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Allergens [CS]
    • Dietary Proteins [CS]
    • Fish Proteins
    • Dietary [EXT]

    NDC Crossover Matching brand name "Halibut" or generic name "Halibut"

    NDCBrand NameGeneric Name
    0268-6236HALIBUTATLANTIC HALIBUT
    0268-7130HALIBUTHIPPOGLOSSUS HIPPOGLOSSUS
    36987-1218HalibutHalibut
    36987-1219HalibutHalibut
    36987-1220HalibutHalibut
    36987-1221HalibutHalibut
    49288-0251HalibutHalibut
    49288-0252HalibutHalibut
    54575-401HALIBUTpacific halibut

    Trademark Results [Halibut]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    HALIBUT
    HALIBUT
    88861382 not registered Live/Pending
    Koch OÜ
    2020-04-06
    HALIBUT
    HALIBUT
    78686563 not registered Dead/Abandoned
    Laboratorios Andromaco Lda
    2005-08-05

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