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United States · US · US:62332-734_69114afa-390f-4134-9055-d0b539d45c96
Nifedipine
Orange BookUNIISPLATC C08CA05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlembic Pharmaceuticals Inc.
CountryUS (United States)
ATC codeC08CA05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116233273431100 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-734-31)
Annotations
UNII (FDA Substance ID)
I9ZF7L6G2L
NIFEDIPINE
RxCUI 7417
Orange Book
A216896
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": "62332-734_69114afa-390f-4134-9055-d0b539d45c96",
"productndc": "62332-734",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "216896",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB2",
"strength": "30MG",
"product_no": "001",
"approval_date": "Nov 18, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB2",
"strength": "60MG",
"product_no": "002",
"approval_date": "Nov 18, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB2",
"strength": "90MG",
"product_no": "003",
"approval_date": "Nov 18, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NIFEDIPINE",
"proprietary_name": "Nifedipine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA216896",
"marketing_category": "ANDA",
"nonproprietary_name": "Nifedipine",
"start_marketing_date": "20221123",
"active_numerator_strength": "90"
}Related drugs
Other records sharing ATC code C08CA05.
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