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United States · US · US:68682-302_ae224c35-5c76-4a51-a7b3-ac20f5e92bca

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
    6868230210
    100 TABLET in 1 BOTTLE (68682-302-10)

Annotations

UNII (FDA Substance ID)
KVI301NA53
PYRIDOSTIGMINE BROMIDE
RxCUI 9001
Orange Book
N009829
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": "68682-302_ae224c35-5c76-4a51-a7b3-ac20f5e92bca",
  "productndc": "68682-302",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "009829",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "002",
        "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": "NDA009829",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Pyridostigmine Bromide",
  "start_marketing_date": "20071030",
  "active_numerator_strength": "60"
}

Related drugs

Other records sharing ATC code N07AA02.

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