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United States · US · US:47781-335_0429e410-7623-2f45-6170-d4a2eadd8742

Pyridostigmine Bromide

Orange BookUNIISPLATC N07AA02

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

Identification

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

Packs · 1

  • ndc11
    4778133530
    30 TABLET, EXTENDED RELEASE in 1 BOTTLE (47781-335-30)

Annotations

UNII (FDA Substance ID)
KVI301NA53
PYRIDOSTIGMINE BROMIDE
RxCUI 9001
Orange Book
A204737
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": "47781-335_0429e410-7623-2f45-6170-d4a2eadd8742",
  "productndc": "47781-335",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "204737",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "180MG",
        "product_no": "001",
        "approval_date": "Jun 26, 2015"
      }
    ],
    "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": "ANDA204737",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pyridostigmine Bromide",
  "start_marketing_date": "20150629",
  "active_numerator_strength": "180"
}

Related drugs

Other records sharing ATC code N07AA02.

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