Nicardipine Hydrochloride

Orange BookUNIISPLATC C08CA04

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

Identification

ManufacturerWest-Ward Pharmaceuticals Corp

CountryUS (United States)

ATC codeC08CA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0143959310
10 VIAL in 1 CARTON (0143-9593-10) / 10 mL in 1 VIAL (0143-9593-01)

Annotations

UNII (FDA Substance ID)

K5BC5011K3

NICARDIPINE HYDROCHLORIDE

RxCUI 235230

Orange Book

N022276

APAPAP

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": "INTRAVENOUS",
  "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": "0143-9593_6d6e45d5-e6b1-402c-93c1-3106ff8145d4",
  "productndc": "0143-9593",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "022276",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "25MG/10ML (2.5MG/ML)",
        "product_no": "001",
        "approval_date": "Jul 24, 2008"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "20MG/200ML (0.1MG/ML)",
        "product_no": "002",
        "approval_date": "Apr 7, 2016"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "40MG/200ML (0.2MG/ML)",
        "product_no": "003",
        "approval_date": "Apr 7, 2016"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NICARDIPINE HYDROCHLORIDE",
  "proprietary_name": "Nicardipine Hydrochloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA022276",
  "marketing_category": "NDA",
  "nonproprietary_name": "Nicardipine Hydrochloride",
  "start_marketing_date": "20120302",
  "active_numerator_strength": "2.5"
}

Related drugs

Other records sharing ATC code C08CA04.

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