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United States · US · US:69315-211_4f9b849c-719a-492b-9889-6766a4544c54
NIFEdipine
Orange BookUNIISPLATC C08CA05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLeading Pharma, LLC
CountryUS (United States)
ATC codeC08CA05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116931521101100 CAPSULE in 1 BOTTLE, PLASTIC (69315-211-01)
Annotations
UNII (FDA Substance ID)
I9ZF7L6G2L
NIFEDIPINE
RxCUI 7417
Orange Book
A073250
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "I9ZF7L6G2L",
"rxcui": "7417",
"inchikey": "HYIMSNHJOBLJNT-UHFFFAOYSA-N",
"display_name": "NIFEDIPINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"518d39af-0be1-acbc-e063-6294a90a4ada": {
"match": "brand_token",
"title": "NIFEDIPINE TABLET, FILM COATED, EXTENDED RELEASE [COUPLER LLC]",
"spl_version": "1",
"published_date": "2026-05-13"
}
},
"productid": "69315-211_4f9b849c-719a-492b-9889-6766a4544c54",
"productndc": "69315-211",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "073250",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Oct 8, 1991"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NIFEDIPINE",
"proprietary_name": "NIFEdipine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA073250",
"marketing_category": "ANDA",
"nonproprietary_name": "NIFEdipine",
"start_marketing_date": "20161123",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code C08CA05.
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