NDC 65044-3429

Food - Plant Source, Orange Citrus sinensis

Orange Citrus Sinensis

Food - Plant Source, Orange Citrus sinensis is a Percutaneous Injection, Solution in the Non-standardized Allergenic category. It is labeled and distributed by Jubilant Hollisterstier Llc. The primary component is Orange.

Product ID65044-3429_5c97b4db-dd8b-48ca-8321-82ebf95159ee
NDC65044-3429
Product TypeNon-standardized Allergenic
Proprietary NameFood - Plant Source, Orange Citrus sinensis
Generic NameOrange Citrus Sinensis
Dosage FormInjection, Solution
Route of AdministrationPERCUTANEOUS
Marketing Start Date1941-04-19
Marketing CategoryBLA / BLA
Application NumberBLA103888
Labeler NameJubilant HollisterStier LLC
Substance NameORANGE
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],Fruit Proteins [EXT]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 65044-3429-1

5 mL in 1 VIAL (65044-3429-1)
Marketing Start Date1941-04-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65044-3429-1 [65044342901]

Food - Plant Source, Orange Citrus sinensis INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103888
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1941-04-19

Drug Details

Active Ingredients

IngredientStrength
ORANGE.1 g/mL

Pharmacological Class

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

NDC Crossover Matching brand name "Food - Plant Source, Orange Citrus sinensis" or generic name "Orange Citrus Sinensis"

NDCBrand NameGeneric Name
65044-3428Food - Plant Source, Orange Citrus sinensisOrange Citrus sinensis
65044-3429Food - Plant Source, Orange Citrus sinensisOrange Citrus sinensis

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