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United States · US · US:62175-260_2b91b384-4c20-4162-a717-9dc53ea834cc
Nifedipine
Orange BookUNIISPLATC C08CA05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLannett Company, Inc.
CountryUS (United States)
ATC codeC08CA05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116217526037100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62175-260-37)
- ndc11621752604690 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62175-260-46)
- ndc116217526055300 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62175-260-55)
Annotations
UNII (FDA Substance ID)
I9ZF7L6G2L
NIFEDIPINE
RxCUI 7417
Orange Book
A077127
AB2AB2AB2
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": "62175-260_2b91b384-4c20-4162-a717-9dc53ea834cc",
"productndc": "62175-260",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "077127",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB2",
"strength": "30MG",
"product_no": "001",
"approval_date": "Nov 21, 2005"
},
{
"rs": false,
"rld": false,
"te_code": "AB2",
"strength": "60MG",
"product_no": "002",
"approval_date": "Nov 21, 2005"
},
{
"rs": false,
"rld": false,
"te_code": "AB2",
"strength": "90MG",
"product_no": "003",
"approval_date": "Oct 3, 2007"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NIFEDIPINE",
"proprietary_name": "Nifedipine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA077127",
"marketing_category": "ANDA",
"nonproprietary_name": "Nifedipine",
"start_marketing_date": "20051121",
"active_numerator_strength": "30"
}Related drugs
Other records sharing ATC code C08CA05.
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