Pyridostigmine Bromide

Orange BookUNIISPLATC N07AA02

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

Identification

ManufacturerMethod Pharmaceuticals, LLC

CountryUS (United States)

ATC codeN07AA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5865781021
21 TABLET in 1 BOTTLE (58657-810-21)

Annotations

UNII (FDA Substance ID)

KVI301NA53

PYRIDOSTIGMINE BROMIDE

RxCUI 9001

Orange Book

A211181

ABAB

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": "58657-810_41b66d64-08b1-bd0c-e063-6394a90a5b86",
  "productndc": "58657-810",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "211181",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "001",
        "approval_date": "Jul 20, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "002",
        "approval_date": "May 14, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PYRIDOSTIGMINE BROMIDE",
  "proprietary_name": "Pyridostigmine Bromide",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211181",
  "marketing_category": "ANDA",
  "nonproprietary_name": "PYRIDOSTIGMINE BROMIDE",
  "start_marketing_date": "20190601",
  "active_numerator_strength": "30"
}

Related drugs

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