METOLAZONE

Orange BookUNIISPLATC C03BA08

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAdvagen Pharma Limited

CountryUS (United States)

ATC codeC03BA08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7288805401
100 TABLET in 1 BOTTLE (72888-054-01)

Annotations

UNII (FDA Substance ID)

TZ7V40X7VX

METOLAZONE

RxCUI 6916

Orange Book

A215184

ABABAB

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": "72888-054_486ae202-9be8-35ef-e063-6294a90adb8a",
  "productndc": "72888-054",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "215184",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Aug 20, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Aug 20, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Aug 20, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METOLAZONE",
  "proprietary_name": "METOLAZONE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA215184",
  "marketing_category": "ANDA",
  "nonproprietary_name": "METOLAZONE",
  "start_marketing_date": "20210820",
  "active_numerator_strength": "10"
}

Related drugs

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