Nicardipine Hydrochloride

Orange BookUNIISPLATC C08CA04

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerEpic Pharma, LLC

CountryUS (United States)

ATC codeC08CA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
4280650101
100 CAPSULE in 1 BOTTLE (42806-501-01)
ndc11
4280650105
500 CAPSULE in 1 BOTTLE (42806-501-05)
ndc11
4280650109
90 CAPSULE in 1 BOTTLE (42806-501-09)
ndc11
4280650110
1000 CAPSULE in 1 BOTTLE (42806-501-10)

Annotations

UNII (FDA Substance ID)

K5BC5011K3

NICARDIPINE HYDROCHLORIDE

RxCUI 235230

Orange Book

A074928

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "K5BC5011K3",
    "rxcui": "235230",
    "inchikey": "AIKVCUNQWYTVTO-UHFFFAOYSA-N",
    "display_name": "NICARDIPINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "b0e2bed3-f928-43ab-a05c-275bedc9856f": {
      "match": "brand_token",
      "title": "NICARDIPINE HYDROCHLORIDE INJECTION [LIFESTAR PHARMA LLC]",
      "spl_version": "3",
      "published_date": "2026-04-27"
    }
  },
  "productid": "42806-501_cdaf4385-811f-4e33-9990-b4e2586b81b3",
  "productndc": "42806-501",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "074928",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Mar 19, 1998"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "002",
        "approval_date": "Mar 19, 1998"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NICARDIPINE HYDROCHLORIDE",
  "proprietary_name": "Nicardipine Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA074928",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nicardipine Hydrochloride",
  "start_marketing_date": "20100505",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code C08CA04.

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