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United States · US · US:48433-069_4c1322a2-fc39-f1bb-e063-6394a90a39a2
Metolazone
Orange BookUNIISPLATC C03BA08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSafecor Health LLC
CountryUS (United States)
ATC codeC03BA08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc114843306920100 BLISTER PACK in 1 CARTON (48433-069-20) / 1 TABLET in 1 BLISTER PACK (48433-069-01)
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": "48433-069_4c1322a2-fc39-f1bb-e063-6394a90a39a2",
"productndc": "48433-069",
"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": "20260219",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code C03BA08.
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