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United States · US · US:68788-8164_5c357886-29f3-40df-9dfb-eefcab465cc8
Nifedipine
Orange BookUNIISPLATC C08CA05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeC08CA05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc116878881641100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8164-1)
- ndc11687888164330 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8164-3)
- ndc11687888164660 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8164-6)
- ndc11687888164990 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8164-9)
Annotations
UNII (FDA Substance ID)
I9ZF7L6G2L
NIFEDIPINE
RxCUI 7417
Orange Book
A210614
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": "68788-8164_5c357886-29f3-40df-9dfb-eefcab465cc8",
"productndc": "68788-8164",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "210614",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB2",
"strength": "30MG",
"product_no": "001",
"approval_date": "Mar 12, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB2",
"strength": "60MG",
"product_no": "002",
"approval_date": "Mar 12, 2019"
},
{
"rs": true,
"rld": false,
"te_code": "AB2",
"strength": "90MG",
"product_no": "003",
"approval_date": "Mar 12, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NIFEDIPINE",
"proprietary_name": "Nifedipine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA210614",
"marketing_category": "ANDA",
"nonproprietary_name": "nifedipine",
"start_marketing_date": "20220404",
"active_numerator_strength": "60"
}Related drugs
Other records sharing ATC code C08CA05.
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