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United States · US · US:16571-833_b46177b2-68dc-4958-a4ec-d4bd6d887456

Pryidostigmine Bromide

Orange BookUNIISPLATC N07AA02

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

Identification

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

Packs · 1

  • ndc11
    1657183316
    473 mL in 1 BOTTLE, PLASTIC (16571-833-16)

Annotations

UNII (FDA Substance ID)
KVI301NA53
PYRIDOSTIGMINE BROMIDE
RxCUI 9001
Orange Book
A208797
AA
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": {
    "d42f2d2e-b9f8-7c22-e053-2995a90a9661": {
      "match": "brand_token",
      "title": "PRYIDOSTIGMINE BROMIDE (PYRIDOSTIGMINE BROMIDE) SOLUTION [APNAR PHARMA LP]",
      "spl_version": "3",
      "published_date": "2025-01-13"
    }
  },
  "productid": "16571-833_b46177b2-68dc-4958-a4ec-d4bd6d887456",
  "productndc": "16571-833",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "208797",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "60MG/5ML",
        "product_no": "001",
        "approval_date": "Jan 9, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PYRIDOSTIGMINE BROMIDE",
  "proprietary_name": "Pryidostigmine Bromide",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA208797",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pyridostigmine Bromide",
  "start_marketing_date": "20220915",
  "active_numerator_strength": "60"
}

Related drugs

Other records sharing ATC code N07AA02.

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