Nicardipine Hydrochloride

Orange BookUNIISPLATC C08CA04

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

Identification

ManufacturerGlenmark Pharmaceuticals Inc., USA

CountryUS (United States)

ATC codeC08CA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6846212005
500 CAPSULE in 1 BOTTLE (68462-120-05)
ndc11
6846212090
90 CAPSULE in 1 BOTTLE (68462-120-90)

Annotations

UNII (FDA Substance ID)

K5BC5011K3

NICARDIPINE HYDROCHLORIDE

RxCUI 235230

Orange Book

A216357

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": "68462-120_eb131915-222b-49d9-8e66-cd0f0afd066c",
  "productndc": "68462-120",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "216357",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Dec 16, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "002",
        "approval_date": "Dec 16, 2022"
      }
    ],
    "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": "ANDA216357",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nicardipine Hydrochloride",
  "start_marketing_date": "20221216",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code C08CA04.

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