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United States · US · US:72162-1277_d713ebf4-6b8a-44ed-9fc2-0e1b34f6bb5f
Nifedipine
Orange BookUNIISPLATC C08CA05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeC08CA05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc117216212771100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-1277-1)
- ndc11721621277330 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-1277-3)
- ndc11721621277990 TABLET, EXTENDED RELEASE in 1 BOTTLE (72162-1277-9)
Annotations
UNII (FDA Substance ID)
I9ZF7L6G2L
NIFEDIPINE
RxCUI 7417
Orange Book
A203126
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": "72162-1277_d713ebf4-6b8a-44ed-9fc2-0e1b34f6bb5f",
"productndc": "72162-1277",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "203126",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB2",
"strength": "30MG",
"product_no": "001",
"approval_date": "Apr 3, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AB2",
"strength": "60MG",
"product_no": "002",
"approval_date": "Apr 3, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AB2",
"strength": "90MG",
"product_no": "003",
"approval_date": "Apr 3, 2014"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NIFEDIPINE",
"proprietary_name": "Nifedipine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA203126",
"marketing_category": "ANDA",
"nonproprietary_name": "Nifedipine",
"start_marketing_date": "20141101",
"active_numerator_strength": "30"
}Related drugs
Other records sharing ATC code C08CA05.
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