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United States · US · US:59651-297_4d72a04e-43a6-4fa4-bd1c-1360c4539d71
Nifedipine
Orange BookUNIISPLATC C08CA05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeC08CA05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc115965129701100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-297-01)
Annotations
UNII (FDA Substance ID)
I9ZF7L6G2L
NIFEDIPINE
RxCUI 7417
Orange Book
A213361
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": "59651-297_4d72a04e-43a6-4fa4-bd1c-1360c4539d71",
"productndc": "59651-297",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "213361",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "30MG",
"product_no": "001",
"approval_date": "Jul 19, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "60MG",
"product_no": "002",
"approval_date": "Jul 19, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "90MG",
"product_no": "003",
"approval_date": "Jul 19, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NIFEDIPINE",
"proprietary_name": "Nifedipine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA213361",
"marketing_category": "ANDA",
"nonproprietary_name": "Nifedipine",
"start_marketing_date": "20210719",
"active_numerator_strength": "90"
}Related drugs
Other records sharing ATC code C08CA05.
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