Diltiazem Hydrochloride

In shortageOrange BookUNIISPLATC C05AE03

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

Identification

ManufacturerHospira, Inc.

CountryUS (United States)

ATC codeC05AE03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0409435003
10 VIAL, PATENT DELIVERY SYSTEM in 1 TRAY (0409-4350-03) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, PATENT DELIVERY SYSTEM (0409-4350-13)

Annotations

UNII (FDA Substance ID)

OLH94387TE

DILTIAZEM HYDROCHLORIDE

RxCUI 203211

Orange Book

A075853

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": "INTRAVENOUS",
  "spl_meta": {
    "f276d9fe-a685-4d99-ad82-d4452ef4ba98": {
      "match": "brand_token",
      "title": "DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, LLC]",
      "spl_version": "10",
      "published_date": "2026-06-02"
    }
  },
  "productid": "0409-4350_9e518c0c-b7a9-457c-9ca5-6b6c132f985e",
  "productndc": "0409-4350",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "075853",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "100MG/VIAL",
        "product_no": "001",
        "approval_date": "Dec 17, 2002"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DILTIAZEM HYDROCHLORIDE",
  "shortage_reason": "Diltiazem Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "Diltiazem Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075853",
  "marketing_category": "ANDA",
  "nonproprietary_name": "DILTIAZEM HYDROCHLORIDE",
  "start_marketing_date": "20050430",
  "active_numerator_strength": "100"
}

Related drugs

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