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United States · US · US:43353-931_5e3b0779-f81b-410e-820e-5cd76dad6bf5
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
- ndc1143353931099000 TABLET in 1 BOTTLE, PLASTIC (43353-931-09)
Annotations
UNII (FDA Substance ID)
TZ7V40X7VX
METOLAZONE
RxCUI 6916
Orange Book
A076698
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": "43353-931_5e3b0779-f81b-410e-820e-5cd76dad6bf5",
"productndc": "43353-931",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "076698",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2.5MG",
"product_no": "001",
"approval_date": "Dec 23, 2003"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "002",
"approval_date": "Oct 19, 2004"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "003",
"approval_date": "Oct 19, 2004"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "METOLAZONE",
"proprietary_name": "Metolazone",
"active_ingred_unit": "mg/1",
"application_number": "ANDA076698",
"marketing_category": "ANDA",
"nonproprietary_name": "metolazone",
"start_marketing_date": "20041019",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code C03BA08.
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