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United States · US · US:64850-910_194819ab-8bf2-4f80-b9bb-a1209af1ba21

Isradipine

Orange BookUNIISPLATC C08CA03

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

Identification

ManufacturerElite Laboratories, Inc.
CountryUS (United States)
ATC codeC08CA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6485091001
    100 CAPSULE in 1 BOTTLE (64850-910-01)
  • ndc11
    6485091005
    500 CAPSULE in 1 BOTTLE (64850-910-05)

Annotations

UNII (FDA Substance ID)
YO1UK1S598
ISRADIPINE
RxCUI 33910
Orange Book
A077169
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": "64850-910_194819ab-8bf2-4f80-b9bb-a1209af1ba21",
  "productndc": "64850-910",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "077169",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Apr 24, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Apr 24, 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": "ANDA077169",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Isradipine",
  "start_marketing_date": "20221228",
  "active_numerator_strength": "2.5"
}

Related drugs

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