Cardizem

In shortageOrange BookUNIISPLATC C05AE03

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

Identification

ManufacturerBausch Health US LLC

CountryUS (United States)

ATC codeC05AE03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0187077247
100 TABLET, COATED in 1 BOTTLE (0187-0772-47)

Annotations

UNII (FDA Substance ID)

OLH94387TE

DILTIAZEM HYDROCHLORIDE

RxCUI 203211

Orange Book

N018602

ABABABAB

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": "0187-0772_340462fa-5523-448e-e063-6294a90a4eab",
  "productndc": "0187-0772",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "018602",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "001",
        "approval_date": "Nov 5, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "002",
        "approval_date": "Nov 5, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "90MG",
        "product_no": "003",
        "approval_date": "Dec 8, 1986"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "120MG",
        "product_no": "004",
        "approval_date": "Dec 8, 1986"
      }
    ],
    "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",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA018602",
  "marketing_category": "NDA",
  "nonproprietary_name": "Diltiazem Hydrochloride",
  "start_marketing_date": "20101225",
  "active_numerator_strength": "60"
}

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