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United States · US · US:64950-250_74da603c-8c7e-4823-a2a7-82e6ae007531
Isosorbide Mononitrate
Orange BookUNIISPLATC C01DA14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGenus Lifesciences Inc.
CountryUS (United States)
ATC codeC01DA14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116495025001100 TABLET in 1 BOTTLE (64950-250-01)
Annotations
UNII (FDA Substance ID)
LX1OH63030
ISOSORBIDE MONONITRATE
RxCUI 28004
Orange Book
A075037
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": "64950-250_74da603c-8c7e-4823-a2a7-82e6ae007531",
"productndc": "64950-250",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "075037",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "001",
"approval_date": "Oct 30, 1998"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Oct 30, 1998"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ISOSORBIDE MONONITRATE",
"proprietary_name": "Isosorbide Mononitrate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA075037",
"marketing_category": "ANDA",
"nonproprietary_name": "Isosorbide Mononitrate",
"start_marketing_date": "20260409",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code C01DA14.
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