Isradipine

Orange BookUNIISPLATC C08CA03

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

Identification

ManufacturerTeva Pharmaceuticals USA, Inc.

CountryUS (United States)

ATC codeC08CA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
1625254001
100 CAPSULE in 1 BOTTLE (16252-540-01)

Annotations

UNII (FDA Substance ID)

YO1UK1S598

ISRADIPINE

RxCUI 33910

Orange Book

A077317

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "YO1UK1S598",
    "rxcui": "33910",
    "inchikey": "HMJIYCCIJYRONP-UHFFFAOYSA-N",
    "display_name": "ISRADIPINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "fdb4c50e-6e6f-a43d-e053-6294a90aa24f": {
      "match": "brand_token",
      "title": "ISRADIPINE CAPSULE [AVKARE]",
      "spl_version": "2",
      "published_date": "2026-01-15"
    }
  },
  "productid": "16252-540_ac19e8fb-dc66-4e27-8109-d9ac5bf9b8e9",
  "productndc": "16252-540",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "077317",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Jan 5, 2006"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Jan 5, 2006"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ISRADIPINE",
  "proprietary_name": "Isradipine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077317",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Isradipine",
  "start_marketing_date": "20060105",
  "active_numerator_strength": "5"
}

Related drugs

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