NDC 49643-399

Black Cottonwood Pollen

Populus Trichocarpa

Black Cottonwood Pollen 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 Populus Trichocarpa Pollen.

Product ID49643-399_4f1be4f6-9f9e-5c19-e054-00144ff8d46c
NDC49643-399
Product TypeNon-standardized Allergenic
Proprietary NameBlack Cottonwood Pollen
Generic NamePopulus Trichocarpa
Dosage FormInjection
Route of AdministrationCUTANEOUS; INTRADERMAL; SUBCUTANEOUS
Marketing Start Date1974-03-12
Marketing CategoryBLA / BLA
Application NumberBLA102211
Labeler NameAllermed Laboratories, Inc.
Substance NamePOPULUS TRICHOCARPA POLLEN
Active Ingredient Strength0 g/mL
Pharm ClassesNon-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 49643-399-05

5 mL in 1 VIAL, MULTI-DOSE (49643-399-05)
Marketing Start Date1974-03-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49643-399-10 [49643039910]

Black Cottonwood Pollen INJECTION
Marketing CategoryBLA
Application NumberBLA102211
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1974-03-12

NDC 49643-399-50 [49643039950]

Black Cottonwood Pollen INJECTION
Marketing CategoryBLA
Application NumberBLA102211
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1974-03-12

NDC 49643-399-30 [49643039930]

Black Cottonwood Pollen INJECTION
Marketing CategoryBLA
Application NumberBLA102211
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1974-03-12

NDC 49643-399-05 [49643039905]

Black Cottonwood Pollen INJECTION
Marketing CategoryBLA
Application NumberBLA102211
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1974-03-12

Drug Details

Active Ingredients

IngredientStrength
POPULUS TRICHOCARPA POLLEN.05 g/mL

Pharmacological Class

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

NDC Crossover Matching brand name "Black Cottonwood Pollen" or generic name "Populus Trichocarpa"

NDCBrand NameGeneric Name
22840-1474Black Cottonwood PollenPopulus trichocarpa
22840-1475Black Cottonwood PollenPopulus trichocarpa
22840-1477Black Cottonwood PollenPopulus trichocarpa
22840-4440Black Cottonwood PollenPopulus trichocarpa
22840-5420Black Cottonwood PollenPopulus trichocarpa
49643-399Black Cottonwood PollenPopulus trichocarpa

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