Nicardipine Hydrochloride in Sodium Chloride

Orange BookUNIISPLATC C08CA04

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

Identification

ManufacturerWG Critical Care, LLC

CountryUS (United States)

ATC codeC08CA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4456785012
12 BAG in 1 CARTON (44567-850-12) / 200 mL in 1 BAG (44567-850-01)

Annotations

UNII (FDA Substance ID)

K5BC5011K3

NICARDIPINE HYDROCHLORIDE

RxCUI 235230

Orange Book

A203978

APAP

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": "44567-850_9ffe6b6f-b8bc-413f-9bec-7639e9d71d3d",
  "productndc": "44567-850",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "203978",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "20MG/200ML (0.1MG/ML)",
        "product_no": "001",
        "approval_date": "Apr 17, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "40MG/200ML (0.2MG/ML)",
        "product_no": "002",
        "approval_date": "Apr 17, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NICARDIPINE HYDROCHLORIDE",
  "proprietary_name": "Nicardipine Hydrochloride in Sodium Chloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA203978",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nicardipine Hydrochloride",
  "start_marketing_date": "20250710",
  "active_numerator_strength": ".1"
}

Related drugs

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