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United States · US · US:42799-960_7443a5b6-6153-4227-870c-3c710f1f2174
Isosorbide Mononitrate
Orange BookUNIISPLATC C01DA14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEdenbridge Pharmaceuticals LLC.
CountryUS (United States)
ATC codeC01DA14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc114279996001100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42799-960-01)
Annotations
UNII (FDA Substance ID)
LX1OH63030
ISOSORBIDE MONONITRATE
RxCUI 28004
Orange Book
A210822
AB
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": "42799-960_7443a5b6-6153-4227-870c-3c710f1f2174",
"productndc": "42799-960",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "210822",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "120MG",
"product_no": "001",
"approval_date": "Aug 29, 2018"
}
],
"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": "ANDA210822",
"marketing_category": "ANDA",
"nonproprietary_name": "Isosorbide Mononitrate",
"start_marketing_date": "20181115",
"active_numerator_strength": "120"
}Related drugs
Other records sharing ATC code C01DA14.
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