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United States · US · US:81005-125_4575818c-096e-64e5-e063-6294a90ad3b7
METOLAZONE
Orange BookUNIISPLATC C03BA08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAarkish Pharmaceuticals NJ Inc.
CountryUS (United States)
ATC codeC03BA08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc118100512501100 TABLET in 1 BOTTLE (81005-125-01)
- ndc1181005125101000 TABLET in 1 BOTTLE (81005-125-10)
Annotations
UNII (FDA Substance ID)
TZ7V40X7VX
METOLAZONE
RxCUI 6916
Orange Book
A216216
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": "81005-125_4575818c-096e-64e5-e063-6294a90ad3b7",
"productndc": "81005-125",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "216216",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2.5MG",
"product_no": "001",
"approval_date": "Oct 25, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "002",
"approval_date": "Oct 25, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "003",
"approval_date": "Oct 25, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "METOLAZONE",
"proprietary_name": "METOLAZONE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA216216",
"marketing_category": "ANDA",
"nonproprietary_name": "metolazone",
"start_marketing_date": "20230815",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code C03BA08.
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