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United States · US · US:69097-008_d477e259-4e07-433c-b230-d3dd63331866

NICARDIPINE HYDROCHLORIDE

Orange BookUNIISPLATC C08CA04

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerCipla USA Inc.
CountryUS (United States)
ATC codeC08CA04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6909700822
    10 BAG in 1 CARTON (69097-008-22) / 200 mL in 1 BAG (69097-008-45)

Annotations

UNII (FDA Substance ID)
CZ5312222S
NICARDIPINE
RxCUI 7396
Orange Book
A215592
APAP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "CZ5312222S",
    "rxcui": "7396",
    "inchikey": "ZBBHBTPTTSWHBA-UHFFFAOYSA-N",
    "display_name": "NICARDIPINE",
    "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": "69097-008_d477e259-4e07-433c-b230-d3dd63331866",
  "productndc": "69097-008",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "215592",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "20MG/200ML (0.1MG/ML)",
        "product_no": "001",
        "approval_date": "Sep 24, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "40MG/200ML (0.2MG/ML)",
        "product_no": "002",
        "approval_date": "Sep 24, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NICARDIPINE",
  "proprietary_name": "NICARDIPINE HYDROCHLORIDE",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA215592",
  "marketing_category": "ANDA",
  "nonproprietary_name": "nicardipine hydrochloride",
  "start_marketing_date": "20241002",
  "active_numerator_strength": ".2"
}

Related drugs

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