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United States · US · US:70709-085_8716de8d-f4b6-4192-892c-cb22b511257c
ORMALVI
Orange BookUNIISPLATC S01EC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCycle Pharmaceuticals Ltd.
CountryUS (United States)
ATC codeS01EC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc117070908510100 TABLET in 1 BOTTLE (70709-085-10)
Annotations
UNII (FDA Substance ID)
VVJ6673MHY
DICHLORPHENAMIDE
RxCUI 3353
Orange Book
A215924
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "VVJ6673MHY",
"rxcui": "3353",
"inchikey": "GJQPMPFPNINLKP-UHFFFAOYSA-N",
"display_name": "DICHLORPHENAMIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"3989e220-6502-449b-be39-e2689acce08c": {
"match": "brand_token",
"title": "ORMALVI (DICHLORPHENAMIDE) TABLET [CYCLE PHARMACEUTICALS LTD.]",
"spl_version": "3",
"published_date": "2025-11-17"
}
},
"productid": "70709-085_8716de8d-f4b6-4192-892c-cb22b511257c",
"productndc": "70709-085",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "215924",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "001",
"approval_date": "Dec 29, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DICHLORPHENAMIDE",
"proprietary_name": "ORMALVI",
"active_ingred_unit": "mg/1",
"application_number": "ANDA215924",
"marketing_category": "ANDA",
"nonproprietary_name": "Dichlorphenamide",
"start_marketing_date": "20240315",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code S01EC02.
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