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United States · US · US:72458-128_96f61532-26f7-4143-80f4-e62133499d21

Pyridostigmine Bromide

Orange BookUNIISPLATC N07AA02

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

Identification

ManufacturerSurgeon General-Department of the Army (TSG-DA)
CountryUS (United States)
ATC codeN07AA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7245812802
    10 BLISTER PACK in 1 BAG (72458-128-02) / 21 TABLET in 1 BLISTER PACK (72458-128-01)
  • ndc11
    7245812804
    10 BLISTER PACK in 1 BAG (72458-128-04) / 21 TABLET in 1 BLISTER PACK (72458-128-03)

Annotations

UNII (FDA Substance ID)
KVI301NA53
PYRIDOSTIGMINE BROMIDE
RxCUI 9001
Orange Book
N020414
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": "72458-128_96f61532-26f7-4143-80f4-e62133499d21",
  "productndc": "72458-128",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "020414",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "30MG",
        "product_no": "001",
        "approval_date": "Feb 5, 2003"
      }
    ],
    "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": "NDA020414",
  "marketing_category": "NDA",
  "nonproprietary_name": "Pyridostigmine Bromide",
  "start_marketing_date": "19901205",
  "active_numerator_strength": "30"
}

Related drugs

Other records sharing ATC code N07AA02.

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