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United States · US · US:68382-686_c0025ef1-99d7-4b31-9d99-4be010b2b9fb
Nifedipine
Orange BookUNIISPLATC C08CA05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals (USA) Inc.
CountryUS (United States)
ATC codeC08CA05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116838268601100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-686-01)
- ndc1168382686101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-686-10)
- ndc116838268695300 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-686-95)
Annotations
UNII (FDA Substance ID)
I9ZF7L6G2L
NIFEDIPINE
RxCUI 7417
Orange Book
A210012
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": "68382-686_c0025ef1-99d7-4b31-9d99-4be010b2b9fb",
"productndc": "68382-686",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "210012",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB2",
"strength": "30MG",
"product_no": "001",
"approval_date": "Dec 19, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB2",
"strength": "60MG",
"product_no": "002",
"approval_date": "Dec 19, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB2",
"strength": "90MG",
"product_no": "003",
"approval_date": "Dec 19, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NIFEDIPINE",
"proprietary_name": "Nifedipine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA210012",
"marketing_category": "ANDA",
"nonproprietary_name": "Nifedipine",
"start_marketing_date": "20180202",
"active_numerator_strength": "60"
}Related drugs
Other records sharing ATC code C08CA05.
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