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United States · US · US:64850-910_194819ab-8bf2-4f80-b9bb-a1209af1ba21
Isradipine
Orange BookUNIISPLATC C08CA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerElite Laboratories, Inc.
CountryUS (United States)
ATC codeC08CA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116485091001100 CAPSULE in 1 BOTTLE (64850-910-01)
- ndc116485091005500 CAPSULE in 1 BOTTLE (64850-910-05)
Annotations
UNII (FDA Substance ID)
YO1UK1S598
ISRADIPINE
RxCUI 33910
Orange Book
A077169
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "YO1UK1S598",
"rxcui": "33910",
"inchikey": "HMJIYCCIJYRONP-UHFFFAOYSA-N",
"display_name": "ISRADIPINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"fdb4c50e-6e6f-a43d-e053-6294a90aa24f": {
"match": "brand_token",
"title": "ISRADIPINE CAPSULE [AVKARE]",
"spl_version": "2",
"published_date": "2026-01-15"
}
},
"productid": "64850-910_194819ab-8bf2-4f80-b9bb-a1209af1ba21",
"productndc": "64850-910",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "077169",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2.5MG",
"product_no": "001",
"approval_date": "Apr 24, 2006"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "002",
"approval_date": "Apr 24, 2006"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ISRADIPINE",
"proprietary_name": "Isradipine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA077169",
"marketing_category": "ANDA",
"nonproprietary_name": "Isradipine",
"start_marketing_date": "20221228",
"active_numerator_strength": "2.5"
}Related drugs
Other records sharing ATC code C08CA03.
- 🇺🇸IsradipineElite Laboratories, Inc.
- 🇺🇸IsradipineTeva Pharmaceuticals USA, Inc.
- 🇺🇸IsradipineTeva Pharmaceuticals USA, Inc.
- 🇺🇸IsradipineAvKARE
- GBIsradipine 2.5mg tabletsA A H Pharmaceuticals Ltd
- GBIsradipine 2.5mg tabletsAlliance Healthcare (Distribution) Ltd
- GBIsradipine 2.5mg tabletsSandoz Ltd
- GBIsradipine 2.5mg tabletsDE Pharmaceuticals
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