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United States · US · US:68071-4290_1a3dc619-6b11-21b4-e063-6294a90acb1e
Isosorbide Mononitrate
Orange BookUNIISPLATC C01DA14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNuCare Pharmaceuticals,Inc.
CountryUS (United States)
ATC codeC01DA14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11680714290330 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-4290-3)
- ndc11680714290660 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-4290-6)
- ndc11680714290990 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-4290-9)
Annotations
UNII (FDA Substance ID)
LX1OH63030
ISOSORBIDE MONONITRATE
RxCUI 28004
Orange Book
A075522
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": "68071-4290_1a3dc619-6b11-21b4-e063-6294a90acb1e",
"productndc": "68071-4290",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "075522",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "60MG",
"product_no": "001",
"approval_date": "Apr 17, 2000"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "30MG",
"product_no": "002",
"approval_date": "Sep 20, 2016"
}
],
"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": "ANDA075522",
"marketing_category": "ANDA",
"nonproprietary_name": "Isosorbide Mononitrate",
"start_marketing_date": "20170105",
"active_numerator_strength": "30"
}Related drugs
Other records sharing ATC code C01DA14.
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