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United States · US · US:81665-103_dba5d0c5-88bc-4091-b882-43dddc70923e
isosorbide mononitrate
Orange BookUNIISPLATC C01DA14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerOMNIVIUM PHARMACEUTICALS LLC.
CountryUS (United States)
ATC codeC01DA14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc118166510310100 TABLET in 1 BOTTLE (81665-103-10)
Annotations
UNII (FDA Substance ID)
LX1OH63030
ISOSORBIDE MONONITRATE
RxCUI 28004
Orange Book
N020215
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "LX1OH63030",
"rxcui": "28004",
"inchikey": "YWXYYJSYQOXTPL-SLPGGIOYSA-N",
"display_name": "ISOSORBIDE MONONITRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"0a1e317a-7b05-4d30-9bbc-1d4ccd56ba3c": {
"match": "brand_token",
"title": "ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]",
"spl_version": "13",
"published_date": "2026-05-13"
}
},
"productid": "81665-103_dba5d0c5-88bc-4091-b882-43dddc70923e",
"productndc": "81665-103",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "020215",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "20MG",
"product_no": "001",
"approval_date": "Jun 30, 1993"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Jun 30, 1993"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ISOSORBIDE MONONITRATE",
"proprietary_name": "isosorbide mononitrate",
"active_ingred_unit": "mg/1",
"application_number": "NDA020215",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "isosorbide mononitrate",
"start_marketing_date": "20240502",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code C01DA14.
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