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United States · US · US:0615-7767_c8f05814-88ec-44f5-bf13-52590d9f9052
ISOSORBIDE MONONITRATE
Orange BookUNIISPLATC C01DA14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNCS HealthCare of KY, LLC dba Vangard Labs
CountryUS (United States)
ATC codeC01DA14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11061577670515 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-7767-05)
- ndc11061577673930 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-7767-39)
Annotations
UNII (FDA Substance ID)
LX1OH63030
ISOSORBIDE MONONITRATE
RxCUI 28004
Orange Book
A200270
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": "0615-7767_c8f05814-88ec-44f5-bf13-52590d9f9052",
"productndc": "0615-7767",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "200270",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "30MG",
"product_no": "001",
"approval_date": "Jun 3, 2011"
}
],
"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": "ANDA200270",
"marketing_category": "ANDA",
"nonproprietary_name": "ISOSORBIDE MONONITRATE",
"start_marketing_date": "20110603",
"active_numerator_strength": "30"
}Related drugs
Other records sharing ATC code C01DA14.
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