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United States · US · US:49884-151_1ba717f8-b210-40c9-a16e-85edbddaba02

Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride

Orange BookUNIISPLATC A02BX

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

Identification

ManufacturerPar Health USA, LLC
CountryUS (United States)
ATC codeA02BX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4988415154
    120 CAPSULE in 1 CARTON (49884-151-54)

Annotations

UNII (FDA Substance ID)
R3O80H60KX
BISMUTH SUBCITRATE POTASSIUM
RxCUI 1294617
Orange Book
A205770
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "R3O80H60KX",
    "rxcui": "1294617",
    "inchikey": "VBVVJMZCAZRTKA-UHFFFAOYSA-H",
    "display_name": "BISMUTH SUBCITRATE POTASSIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "015ca07a-f6b5-4741-a7b0-821cf6d4e418": {
      "match": "brand_token",
      "title": "BISMUTH (BISMUTH SUBSALICYLATE) TABLET [ALLEGIANT HEALTH]",
      "spl_version": "8",
      "published_date": "2026-05-11"
    }
  },
  "productid": "49884-151_1ba717f8-b210-40c9-a16e-85edbddaba02",
  "productndc": "49884-151",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "205770",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "140MG;125MG;125MG",
        "product_no": "001",
        "approval_date": "Mar 6, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE",
  "proprietary_name": "Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "ANDA205770",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride",
  "start_marketing_date": "20230307",
  "active_numerator_strength": "140; 125; 125"
}

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