NDC 0268-6688

BETULA LENTA POLLEN

White Birch

BETULA LENTA POLLEN is a Intradermal Injection, Solution in the Non-standardized Allergenic category. It is labeled and distributed by Alk-abello, Inc.. The primary component is Betula Lenta Pollen.

Product ID0268-6688_06c812ac-2bfd-444c-b2b9-50076167486c
NDC0268-6688
Product TypeNon-standardized Allergenic
Proprietary NameBETULA LENTA POLLEN
Generic NameWhite Birch
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL
Marketing Start Date1965-01-01
Marketing CategoryBLA / BLA
Application NumberBLA103753
Labeler NameALK-Abello, Inc.
Substance NameBETULA LENTA POLLEN
Active Ingredient Strength1000 [PNU]/mL
Pharm ClassesIncreased Histamine Release [PE],Cell-mediated Immunity [PE],Non-Standardized Pollen Allergenic Extract [EPC],Increased IgG Production [PE],Pollen [CS],Allergens [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0268-6688-05

5 mL in 1 VIAL, MULTI-DOSE (0268-6688-05)
Marketing Start Date1965-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0268-6688-05 [00268668805]

BETULA LENTA POLLEN INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103753
Product TypeNON-STANDARDIZED ALLERGENIC
Marketing Start Date1965-01-01

Drug Details

Active Ingredients

IngredientStrength
BETULA LENTA POLLEN1000 [PNU]/mL

Pharmacological Class

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

NDC Crossover Matching brand name "BETULA LENTA POLLEN" or generic name "White Birch"

NDCBrand NameGeneric Name
0268-1056BETULA LENTA POLLENBirch Black
0268-1057BETULA LENTA POLLENBirch Black
0268-1058BETULA LENTA POLLENBirch Black
0268-1059BETULA LENTA POLLENBirch Black
0268-1069BETULA LENTA POLLENBirch White
0268-1070BETULA LENTA POLLENBirch White
0268-1071BETULA LENTA POLLENBirch White
0268-1072BETULA LENTA POLLENBirch White
0268-1073BETULA LENTA POLLENBirch White
0268-6608BETULA LENTA POLLENBlack Birch
0268-6610BETULA LENTA POLLENWhite Birch
0268-6686BETULA LENTA POLLENBlack Birch
0268-6688BETULA LENTA POLLENWhite Birch
0268-6772BETULA LENTA POLLENWhite Pine
0268-0041CENTER-AL - BETULA LENTA POLLENBETULA LENTA POLLEN
36987-2549White BirchWhite Birch

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