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United States · US · US:58657-941_4a96f40b-ed89-0892-e063-6394a90a947d
Metolazone
Orange BookUNIISPLATC C03BA08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMethod Pharmaceuticals, LLC
CountryUS (United States)
ATC codeC03BA08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc115865794101100 BLISTER PACK in 1 CARTON (58657-941-01) / 1 TABLET in 1 BLISTER PACK (58657-941-10)
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": "58657-941_4a96f40b-ed89-0892-e063-6394a90a947d",
"productndc": "58657-941",
"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": "20260128",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code C03BA08.
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