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United States · US · US:70518-4625_503ac20c-0b86-83cf-e063-6294a90a0ee7
Nifedipine
Orange BookUNIISPLATC C08CA05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeC08CA05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11705184625050 POUCH in 1 BOX (70518-4625-0) / 1 CAPSULE in 1 POUCH (70518-4625-1)
Annotations
UNII (FDA Substance ID)
I9ZF7L6G2L
NIFEDIPINE
RxCUI 7417
Orange Book
A202644
ABAB
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": "70518-4625_503ac20c-0b86-83cf-e063-6294a90a0ee7",
"productndc": "70518-4625",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "202644",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Apr 25, 2013"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "002",
"approval_date": "Apr 25, 2013"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NIFEDIPINE",
"proprietary_name": "Nifedipine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA202644",
"marketing_category": "ANDA",
"nonproprietary_name": "Nifedipine",
"start_marketing_date": "20260424",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code C08CA05.
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