BabyBIG

UNIISPL

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

Identification

ManufacturerCALIFORNIA DEPARTMENT OF PUBLIC HEALTH

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6840311007
1 VIAL, SINGLE-USE in 1 CARTON (68403-1100-7) / 2 mL in 1 VIAL, SINGLE-USE (68403-1100-6)

Annotations

UNII (FDA Substance ID)

X641Y30OA7

HUMAN BOTULINUM NEUROTOXIN A/B IMMUNE GLOBULIN

RxCUI 544488

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "X641Y30OA7",
    "rxcui": "544488",
    "inchikey": null,
    "display_name": "HUMAN BOTULINUM NEUROTOXIN A/B IMMUNE GLOBULIN",
    "substance_type": "structurallyDiverse",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "9ec59262-35c1-4d8e-8451-a7cfbacb0675": {
      "match": "brand_token",
      "title": "BABYBIG (HUMAN BOTULINUM NEUROTOXIN A/B IMMUNE GLOBULIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CALIFORNIA DEPARTMENT OF PUBLIC HEALTH]",
      "spl_version": "14",
      "published_date": "2025-12-10"
    }
  },
  "productid": "68403-1100_1081f6db-619b-4e42-946c-d278789a588a",
  "productndc": "68403-1100",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HUMAN BOTULINUM NEUROTOXIN A/B IMMUNE GLOBULIN",
  "proprietary_name": "BabyBIG",
  "active_ingred_unit": "mg/mL",
  "application_number": "BLA125034",
  "marketing_category": "BLA",
  "nonproprietary_name": "human botulinum neurotoxin a/b immune globulin",
  "start_marketing_date": "20031023",
  "active_numerator_strength": "50"
}

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