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United States · US · US:0904-6449_af7ec13d-7e9f-4407-9588-f61a75bac043
ISOSORBIDE MONONITRATE
Orange BookUNIISPLATC C01DA14
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMajor Pharmaceuticals
CountryUS (United States)
ATC codeC01DA14
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc110904644961100 BLISTER PACK in 1 CARTON (0904-6449-61) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
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": "0904-6449_af7ec13d-7e9f-4407-9588-f61a75bac043",
"productndc": "0904-6449",
"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": "20150105",
"active_numerator_strength": "30"
}Related drugs
Other records sharing ATC code C01DA14.
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