DILTIAZEM HYDROCHLORIDE in SODIUM CHLORIDE

In shortageOrange BookUNIISPLATC C05AE03

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

Identification

ManufacturerWG Critical Care, LLC

CountryUS (United States)

ATC codeC05AE03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4456766210
10 BAG in 1 CARTON (44567-662-10) / 100 mL in 1 BAG (44567-662-01)

Annotations

UNII (FDA Substance ID)

OLH94387TE

DILTIAZEM HYDROCHLORIDE

RxCUI 203211

Orange Book

N218038

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": "44567-662_d3c2dae2-c1e5-469e-ad68-46fe6712d2c7",
  "productndc": "44567-662",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "218038",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "100MG/100ML (1MG/ML)",
        "product_no": "001",
        "approval_date": "Feb 21, 2025"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "250MG/250ML (1MG/ML)",
        "product_no": "002",
        "approval_date": "Feb 21, 2025"
      }
    ],
    "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": "DILTIAZEM HYDROCHLORIDE in SODIUM CHLORIDE",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA218038",
  "marketing_category": "NDA",
  "nonproprietary_name": "Diltiazem Hydrochloride",
  "start_marketing_date": "20250321",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code C05AE03.

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