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United States · US · US:42571-416_47da5a45-3e85-bb97-e063-6294a90a545c
Metolazone
Orange BookUNIISPLATC C03BA08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMicro Labs Limited
CountryUS (United States)
ATC codeC03BA08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc114257141601100 TABLET in 1 CONTAINER (42571-416-01)
- ndc1142571416101000 TABLET in 1 CONTAINER (42571-416-10)
Annotations
UNII (FDA Substance ID)
TZ7V40X7VX
METOLAZONE
RxCUI 6916
Orange Book
A217563
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": "42571-416_47da5a45-3e85-bb97-e063-6294a90a545c",
"productndc": "42571-416",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "217563",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2.5MG",
"product_no": "001",
"approval_date": "Nov 6, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "002",
"approval_date": "Nov 6, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "003",
"approval_date": "Nov 6, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "METOLAZONE",
"proprietary_name": "Metolazone",
"active_ingred_unit": "mg/1",
"application_number": "ANDA217563",
"marketing_category": "ANDA",
"nonproprietary_name": "Metolazone",
"start_marketing_date": "20250301",
"active_numerator_strength": "2.5"
}Related drugs
Other records sharing ATC code C03BA08.
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