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United States · US · US:50090-6802_bef7bd92-1e16-40d7-8158-1ef956cd843f

Metolazone

Orange BookUNIISPLATC C03BA08

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeC03BA08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009068020
    30 TABLET in 1 BOTTLE (50090-6802-0)

Annotations

UNII (FDA Substance ID)
TZ7V40X7VX
METOLAZONE
RxCUI 6916
Orange Book
A213827
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": "50090-6802_bef7bd92-1e16-40d7-8158-1ef956cd843f",
  "productndc": "50090-6802",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "213827",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Mar 30, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Mar 30, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Mar 30, 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": "ANDA213827",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Metolazone",
  "start_marketing_date": "20210515",
  "active_numerator_strength": "2.5"
}

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