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United States · US · US:68382-689_18f1ad21-11a1-4d2d-b5bc-a88ac8c02f45
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 · 5
- ndc116838268901100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-689-01)
- ndc1168382689101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-689-10)
- ndc11683826891690 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-689-16)
- ndc11683826897710 BLISTER PACK in 1 CARTON (68382-689-77) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
- ndc116838268995300 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-689-95)
Annotations
UNII (FDA Substance ID)
I9ZF7L6G2L
NIFEDIPINE
RxCUI 7417
Orange Book
A210184
AB1AB1AB1
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": "68382-689_18f1ad21-11a1-4d2d-b5bc-a88ac8c02f45",
"productndc": "68382-689",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "210184",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "30MG",
"product_no": "001",
"approval_date": "Jun 29, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "60MG",
"product_no": "002",
"approval_date": "Jun 29, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "90MG",
"product_no": "003",
"approval_date": "Jun 29, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NIFEDIPINE",
"proprietary_name": "NIFEDIPINE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA210184",
"marketing_category": "ANDA",
"nonproprietary_name": "NIFEDIPINE",
"start_marketing_date": "20180818",
"active_numerator_strength": "60"
}Related drugs
Other records sharing ATC code C08CA05.
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