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United States · US · US:62175-107_81e3e7e0-b677-4948-9e04-6c3a44ea313b
isosorbide mononitrate
Orange BookUNIISPLATC C01DA14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLannett Company, Inc.
CountryUS (United States)
ATC codeC01DA14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116217510701100 TABLET in 1 BOTTLE (62175-107-01)
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": "62175-107_81e3e7e0-b677-4948-9e04-6c3a44ea313b",
"productndc": "62175-107",
"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": "19930630",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code C01DA14.
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