NDC 36987-2234

Orris Root

Orris Root

Orris Root 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 Iris Germanica Var. Florentina Root.

Product ID36987-2234_ec73bb3c-d08d-4a3b-92a9-d2bfd09da169
NDC36987-2234
Product TypeHuman Prescription Drug
Proprietary NameOrris Root
Generic NameOrris Root
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1972-08-29
Marketing CategoryBLA / BLA
Application NumberBLA102192
Labeler NameNelco Laboratories, Inc.
Substance NameIRIS GERMANICA VAR. FLORENTINA ROOT
Active Ingredient Strength0 g/mL
Pharm ClassesNon-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Plant Proteins [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 36987-2234-1

5 mL in 1 VIAL, MULTI-DOSE (36987-2234-1)
Marketing Start Date1972-08-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36987-2234-1 [36987223401]

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

NDC 36987-2234-2 [36987223402]

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

NDC 36987-2234-3 [36987223403]

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

NDC 36987-2234-4 [36987223404]

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

Drug Details

Active Ingredients

IngredientStrength
IRIS GERMANICA VAR. FLORENTINA ROOT.05 g/mL

OpenFDA Data

SPL SET ID:0fb71326-54c9-4139-befe-06ca832d02c8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 904846
  • 889598
  • 966928
  • 1098356
  • 904681
  • 966958
  • 978958
  • 904965
  • 1014199
  • Pharmacological Class

    • Non-Standardized Plant Allergenic Extract [EPC]
    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Increased IgG Production [PE]
    • Allergens [CS]
    • Plant Proteins [CS]

    NDC Crossover Matching brand name "Orris Root" or generic name "Orris Root"

    NDCBrand NameGeneric Name
    22840-1530Orris RootIris germanica
    22840-1531Orris RootIris germanica
    22840-5515Orris RootIris germanica
    36987-2234Orris RootOrris Root
    36987-2235Orris RootOrris Root
    36987-2236Orris RootOrris Root
    36987-2237Orris RootOrris Root
    49288-0343Orris RootOrris Root
    49288-0344Orris RootOrris Root
    49643-020Orris RootOrris Root
    54575-272ORRIS ROOTiris germanica var. florentina root

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