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United States · US · US:23155-194_b9bbf7c7-2447-4cb1-a0c2-662a9d01d6d9
Nifedipine
Orange BookUNIISPLATC C08CA05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
CountryUS (United States)
ATC codeC08CA05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc112315519401100 CAPSULE in 1 BOTTLE (23155-194-01)
- ndc112315519413300 CAPSULE in 1 BOTTLE (23155-194-13)
Annotations
UNII (FDA Substance ID)
I9ZF7L6G2L
NIFEDIPINE
RxCUI 7417
Orange Book
A202644
ABAB
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": "23155-194_b9bbf7c7-2447-4cb1-a0c2-662a9d01d6d9",
"productndc": "23155-194",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "202644",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "001",
"approval_date": "Apr 25, 2013"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "002",
"approval_date": "Apr 25, 2013"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NIFEDIPINE",
"proprietary_name": "Nifedipine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA202644",
"marketing_category": "ANDA",
"nonproprietary_name": "Nifedipine",
"start_marketing_date": "20101207",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code C08CA05.
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