NDC 49643-113

Monilia

Monilia Sitophila

Monilia is a Cutaneous; Intradermal; Subcutaneous Injection in the Non-standardized Allergenic category. It is labeled and distributed by Allermed Laboratories, Inc.. The primary component is Chrysonilia Sitophila.

Product ID49643-113_4f1be4f6-9f9e-5c19-e054-00144ff8d46c
NDC49643-113
Product TypeNon-standardized Allergenic
Proprietary NameMonilia
Generic NameMonilia Sitophila
Dosage FormInjection
Route of AdministrationCUTANEOUS; INTRADERMAL; SUBCUTANEOUS
Marketing Start Date1974-03-12
Marketing CategoryBLA / BLA
Application NumberBLA102211
Labeler NameAllermed Laboratories, Inc.
Substance NameCHRYSONILIA SITOPHILA
Active Ingredient Strength0 g/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 FlagN
Listing Certified Through2019-12-31

Packaging

NDC 49643-113-05

5 mL in 1 VIAL, MULTI-DOSE (49643-113-05)
Marketing Start Date1974-03-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49643-113-05 [49643011305]

Monilia INJECTION
Marketing CategoryBLA
Application NumberBLA102211
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1974-03-12

NDC 49643-113-10 [49643011310]

Monilia INJECTION
Marketing CategoryBLA
Application NumberBLA102211
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1974-03-12

NDC 49643-113-30 [49643011330]

Monilia INJECTION
Marketing CategoryBLA
Application NumberBLA102211
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1974-03-12

NDC 49643-113-50 [49643011350]

Monilia INJECTION
Marketing CategoryBLA
Application NumberBLA102211
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1974-03-12

Drug Details

Active Ingredients

IngredientStrength
CHRYSONILIA SITOPHILA.1 g/mL

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]

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