Pollens - Trees, Birch Mix

UNIISPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerJubilant HollisterStier LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
6504411682
10 mL in 1 VIAL (65044-1168-2)
ndc11
6504411683
30 mL in 1 VIAL (65044-1168-3)
ndc11
6504411684
50 mL in 1 VIAL (65044-1168-4)

Annotations

UNII (FDA Substance ID)

93963RFO1P

BETULA NIGRA POLLEN

RxCUI 852148

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "93963RFO1P",
    "rxcui": "852148",
    "inchikey": null,
    "display_name": "BETULA NIGRA POLLEN",
    "substance_type": "structurallyDiverse",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "PERCUTANEOUS; SUBCUTANEOUS",
  "spl_meta": {
    "4801db3b-3738-49e0-b047-1bfb4f85349a": {
      "match": "brand_token",
      "title": "POLLENS - WEEDS AND GARDEN PLANTS, SHORT RAGWEED, AMBROSIA ARTEMISIIFOLIA (SHORT RAGWEED, AMBROSIA ARTEMISIIFOLIA) INJECTION, SOLUTION POLLENS - WEEDS AND GARDEN PLANTS, RAGWEED, MIXED AMBROSIA (RAGWEED, MIXED AMBROSIA) INJECTION, SOLUTION [JUBILANT HOLLISTERSTIER LLC]",
      "spl_version": "18",
      "published_date": "2026-04-06"
    }
  },
  "productid": "65044-1168_b92e5087-bcde-4bcc-a899-2e078a039d30",
  "productndc": "65044-1168",
  "dosage_form": "INJECTION, SOLUTION",
  "dea_schedule": null,
  "product_type": "NON-STANDARDIZED ALLERGENIC",
  "substance_name": "BETULA NIGRA POLLEN; BETULA PAPYRIFERA POLLEN; BETULA PENDULA POLLEN",
  "proprietary_name": "Pollens - Trees, Birch Mix",
  "active_ingred_unit": "g/mL; g/mL; g/mL",
  "application_number": "BLA103888",
  "marketing_category": "BLA",
  "nonproprietary_name": "Birch Mix",
  "start_marketing_date": "19410419",
  "active_numerator_strength": ".05; .05; .05"
}

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