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United States · US · US:0187-2046_1771fff3-92c3-48ee-b786-5d6d7c6e6628

Cardizem LA

In shortageOrange BookUNIISPLATC C05AE03

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

Identification

ManufacturerBausch Health US LLC
CountryUS (United States)
ATC codeC05AE03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0187204630
    30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-2046-30)
  • ndc11
    0187204690
    90 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-2046-90)

Annotations

UNII (FDA Substance ID)
OLH94387TE
DILTIAZEM HYDROCHLORIDE
RxCUI 203211
Orange Book
N021392
ABABABABABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Diltiazem Hydrochloride Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "OLH94387TE",
    "rxcui": "203211",
    "inchikey": "HDRXZJPWHTXQRI-BHDTVMLSSA-N",
    "display_name": "DILTIAZEM HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "3e180dc7-c871-4efc-8755-cae882976c8d": {
      "match": "brand_token",
      "title": "CARDIZEM LA (DILTIAZEM HYDROCHLORIDE) TABLET, EXTENDED RELEASE [BAUSCH HEALTH US LLC]",
      "spl_version": "19",
      "published_date": "2025-12-12"
    }
  },
  "productid": "0187-2046_1771fff3-92c3-48ee-b786-5d6d7c6e6628",
  "productndc": "0187-2046",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "021392",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "120MG",
        "product_no": "001",
        "approval_date": "Feb 6, 2003"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "180MG",
        "product_no": "002",
        "approval_date": "Feb 6, 2003"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "240MG",
        "product_no": "003",
        "approval_date": "Feb 6, 2003"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "004",
        "approval_date": "Feb 6, 2003"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "360MG",
        "product_no": "005",
        "approval_date": "Feb 6, 2003"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "420MG",
        "product_no": "006",
        "approval_date": "Feb 6, 2003"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DILTIAZEM HYDROCHLORIDE",
  "shortage_reason": "Diltiazem Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "Cardizem LA",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021392",
  "marketing_category": "NDA",
  "nonproprietary_name": "Diltiazem Hydrochloride",
  "start_marketing_date": "20101225",
  "active_numerator_strength": "180"
}

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