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United States · US · US:71610-285_875c85ff-ca13-41b1-bc4e-ca871c3d2cd1

Metolazone

Orange BookUNIISPLATC C03BA08

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

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeC03BA08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7161028509
    9000 TABLET in 1 BOTTLE (71610-285-09)

Annotations

UNII (FDA Substance ID)
TZ7V40X7VX
METOLAZONE
RxCUI 6916
Orange Book
A076732
AB
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": "71610-285_875c85ff-ca13-41b1-bc4e-ca871c3d2cd1",
  "productndc": "71610-285",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "076732",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "001",
        "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": "ANDA076732",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Metolazone",
  "start_marketing_date": "20031219",
  "active_numerator_strength": "2.5"
}

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