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United States · US · US:68382-659_5439e6be-2d67-4bbd-b72f-3364cb62f907

pyridostigmine bromide

Orange BookUNIISPLATC N07AA02

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

Identification

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

Packs · 4

  • ndc11
    6838265901
    100 TABLET in 1 BOTTLE (68382-659-01)
  • ndc11
    6838265905
    500 TABLET in 1 BOTTLE (68382-659-05)
  • ndc11
    6838265906
    30 TABLET in 1 BOTTLE (68382-659-06)
  • ndc11
    6838265916
    90 TABLET in 1 BOTTLE (68382-659-16)

Annotations

UNII (FDA Substance ID)
KVI301NA53
PYRIDOSTIGMINE BROMIDE
RxCUI 9001
Orange Book
A205650
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": "68382-659_5439e6be-2d67-4bbd-b72f-3364cb62f907",
  "productndc": "68382-659",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "205650",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "001",
        "approval_date": "Jun 22, 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": "ANDA205650",
  "marketing_category": "ANDA",
  "nonproprietary_name": "pyridostigmine bromide",
  "start_marketing_date": "20150807",
  "active_numerator_strength": "60"
}

Related drugs

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