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United States · US · US:51655-798_4973bdb9-ab5a-58eb-e063-6294a90a883e
Nifedipine
Orange BookUNIISPLATC C08CA05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNorthwind Health Company, LLC
CountryUS (United States)
ATC codeC08CA05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11516557982690 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-798-26)
Annotations
UNII (FDA Substance ID)
I9ZF7L6G2L
NIFEDIPINE
RxCUI 7417
Orange Book
A075269
AB1AB1
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": "51655-798_4973bdb9-ab5a-58eb-e063-6294a90a883e",
"productndc": "51655-798",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "075269",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "30MG",
"product_no": "001",
"approval_date": "Dec 4, 2000"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "60MG",
"product_no": "002",
"approval_date": "Dec 4, 2000"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NIFEDIPINE",
"proprietary_name": "Nifedipine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA075269",
"marketing_category": "ANDA",
"nonproprietary_name": "Nifedipine",
"start_marketing_date": "20220218",
"active_numerator_strength": "30"
}Related drugs
Other records sharing ATC code C08CA05.
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