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United States · US · US:71335-1550_c2fce108-407e-4e6a-a003-654fad42839b
Nifedipine
Orange BookUNIISPLATC C08CA05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeC08CA05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc11713351550130 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1550-1)
- ndc117133515502100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1550-2)
- ndc11713351550390 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1550-3)
- ndc11713351550460 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1550-4)
- ndc1171335155057 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1550-5)
- ndc11713351550610 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1550-6)
Annotations
UNII (FDA Substance ID)
I9ZF7L6G2L
NIFEDIPINE
RxCUI 7417
Orange Book
A210614
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": "71335-1550_c2fce108-407e-4e6a-a003-654fad42839b",
"productndc": "71335-1550",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "210614",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB2",
"strength": "30MG",
"product_no": "001",
"approval_date": "Mar 12, 2019"
},
{
"rs": false,
"rld": false,
"te_code": "AB2",
"strength": "60MG",
"product_no": "002",
"approval_date": "Mar 12, 2019"
},
{
"rs": true,
"rld": false,
"te_code": "AB2",
"strength": "90MG",
"product_no": "003",
"approval_date": "Mar 12, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NIFEDIPINE",
"proprietary_name": "Nifedipine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA210614",
"marketing_category": "ANDA",
"nonproprietary_name": "nifedipine",
"start_marketing_date": "20190312",
"active_numerator_strength": "30"
}Related drugs
Other records sharing ATC code C08CA05.
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