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United States · US · US:0781-3040_eaf2bbb9-562b-0e4e-e053-2a95a90abdea

Regonol

Orange BookUNIIATC N07AA02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerSandoz Inc
CountryUS (United States)
ATC codeN07AA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0781304095
    10 AMPULE in 1 CARTON (0781-3040-95) / 2 mL in 1 AMPULE (0781-3040-72)

Annotations

UNII (FDA Substance ID)
KVI301NA53
PYRIDOSTIGMINE BROMIDE
RxCUI 9001
Orange Book
N017398
AP
Raw payload (JSON)
{
  "unii": {
    "unii": "KVI301NA53",
    "rxcui": "9001",
    "inchikey": "VNYBTNPBYXSMOO-UHFFFAOYSA-M",
    "display_name": "PYRIDOSTIGMINE BROMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS; PARENTERAL",
  "productid": "0781-3040_eaf2bbb9-562b-0e4e-e053-2a95a90abdea",
  "productndc": "0781-3040",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "017398",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "5MG/ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PYRIDOSTIGMINE BROMIDE",
  "proprietary_name": "Regonol",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA017398",
  "marketing_category": "NDA",
  "nonproprietary_name": "Pyridostigmine Bromide",
  "start_marketing_date": "20050510",
  "active_numerator_strength": "5"
}

Related drugs

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