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United States · US · US:68682-301_4823269e-594b-4f83-99ce-e9d2436bc5f1

pyridostigmine bromide

Orange BookUNIISPLATC N07AA02

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

Identification

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

Packs · 1

  • ndc11
    6868230130
    30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68682-301-30)

Annotations

UNII (FDA Substance ID)
KVI301NA53
PYRIDOSTIGMINE BROMIDE
RxCUI 9001
Orange Book
N011665
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "KVI301NA53",
    "rxcui": "9001",
    "inchikey": "VNYBTNPBYXSMOO-UHFFFAOYSA-M",
    "display_name": "PYRIDOSTIGMINE BROMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "52d6f195-165a-400b-a13b-489e94bcf0b0": {
      "match": "brand_token",
      "title": "PYRIDOSTIGMINE BROMIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC]",
      "spl_version": "8",
      "published_date": "2026-05-15"
    }
  },
  "productid": "68682-301_4823269e-594b-4f83-99ce-e9d2436bc5f1",
  "productndc": "68682-301",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "011665",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "180MG",
        "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": "pyridostigmine bromide",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA011665",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "pyridostigmine bromide",
  "start_marketing_date": "19590112",
  "active_numerator_strength": "180"
}

Related drugs

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