NICARDIPINE HYDROCHLORIDE

Orange BookUNIISPLATC C08CA04

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

Identification

ManufacturerHF Acquisition Co LLC, DBA HealthFirst

CountryUS (United States)

ATC codeC08CA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5166214821
10 mL in 1 VIAL (51662-1482-1)

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": "51662-1482_2b39b839-0c80-de03-e063-6294a90a243e",
  "productndc": "51662-1482",
  "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/10mL",
  "application_number": "NDA022276",
  "marketing_category": "NDA",
  "nonproprietary_name": "NICARDIPINE HYDROCHLORIDE",
  "start_marketing_date": "20200201",
  "active_numerator_strength": "25"
}

Related drugs

Other records sharing ATC code C08CA04.

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