NDC 49643-116

Phoma

Phoma Betae

Phoma 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 Pleospora Betae.

Product ID49643-116_4f1be4f6-9f9e-5c19-e054-00144ff8d46c
NDC49643-116
Product TypeNon-standardized Allergenic
Proprietary NamePhoma
Generic NamePhoma Betae
Dosage FormInjection
Route of AdministrationCUTANEOUS; INTRADERMAL; SUBCUTANEOUS
Marketing Start Date1974-03-12
Marketing CategoryBLA / BLA
Application NumberBLA102211
Labeler NameAllermed Laboratories, Inc.
Substance NamePLEOSPORA BETAE
Active Ingredient Strength0 g/mL
Pharm ClassesIncreased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS],Non-Standardized Fungal Allergenic Extract [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 49643-116-05

5 mL in 1 VIAL, MULTI-DOSE (49643-116-05)
Marketing Start Date1974-03-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49643-116-30 [49643011630]

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

NDC 49643-116-05 [49643011605]

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

NDC 49643-116-50 [49643011650]

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

NDC 49643-116-10 [49643011610]

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

Drug Details

Active Ingredients

IngredientStrength
PLEOSPORA BETAE.1 g/mL

Pharmacological Class

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

NDC Crossover Matching brand name "Phoma" or generic name "Phoma Betae"

NDCBrand NameGeneric Name
49288-0365PhomaPhoma
49288-0366PhomaPhoma
49643-116PhomaPhoma betae
22840-2618Phoma betaePhoma betae
22840-2674Phoma betaePhoma betae
22840-5632Phoma betaePhoma betae

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