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United States · US · US:71205-963_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
- ndc117120596300100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-963-00)
- ndc11712059633030 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-963-30)
- ndc11712059636060 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-963-60)
- ndc117120596364240 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-963-64)
- ndc117120596367270 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-963-67)
- ndc117120596372120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-963-72)
- ndc117120596378180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-963-78)
- ndc11712059639090 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-963-90)
- ndc117120596396300 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-963-96)
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": "71205-963_ba67d6b0-f638-4264-9bd4-1557223abe83",
"productndc": "71205-963",
"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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