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United States · US · US:71205-964_ba67d6b0-f638-4264-9bd4-1557223abe83
Nifedipine
Orange BookUNIISPLATC C08CA05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeC08CA05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 9
- ndc117120596400100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-964-00)
- ndc11712059643030 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-964-30)
- ndc11712059646060 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-964-60)
- ndc117120596464240 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-964-64)
- ndc117120596467270 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-964-67)
- ndc117120596472120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-964-72)
- ndc117120596478180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-964-78)
- ndc11712059649090 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-964-90)
- ndc117120596496300 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-964-96)
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": "71205-964_ba67d6b0-f638-4264-9bd4-1557223abe83",
"productndc": "71205-964",
"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": "60"
}Related drugs
Other records sharing ATC code C08CA05.
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