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United States · US · US:63629-7875_d764fc31-a1fd-4422-83c8-8504d38b3883

Metolazone

Orange BookUNIISPLATC C03BA08

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeC03BA08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6362978751
    30 TABLET in 1 BOTTLE (63629-7875-1)
  • ndc11
    6362978752
    90 TABLET in 1 BOTTLE (63629-7875-2)

Annotations

UNII (FDA Substance ID)
TZ7V40X7VX
METOLAZONE
RxCUI 6916
Orange Book
A076466
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "TZ7V40X7VX",
    "rxcui": "6916",
    "inchikey": "AQCHWTWZEMGIFD-UHFFFAOYSA-N",
    "display_name": "METOLAZONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "cbfa3d5c-cce9-4afa-b064-06f1e1041eac": {
      "match": "brand_token",
      "title": "METOLAZONE TABLET [AMICI PHARMA, INC]",
      "spl_version": "4",
      "published_date": "2026-04-02"
    }
  },
  "productid": "63629-7875_d764fc31-a1fd-4422-83c8-8504d38b3883",
  "productndc": "63629-7875",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "076466",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Dec 19, 2003"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Dec 19, 2003"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METOLAZONE",
  "proprietary_name": "Metolazone",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076466",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Metolazone",
  "start_marketing_date": "20031219",
  "active_numerator_strength": "5"
}

Related drugs

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