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United States · US · US:51662-1457_132cd9f9-a36c-4e35-e063-6294a90aaa17

DILTIAZEM HCI

In shortageOrange BookUNIISPLATC C05AE03

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

Identification

ManufacturerHF Acquisition Co LLC, DBA HealthFirst
CountryUS (United States)
ATC codeC05AE03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5166214571
    1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, PATENT DELIVERY SYSTEM (51662-1457-1)
  • ndc11
    5166214573
    10 POUCH in 1 CASE (51662-1457-3) / 1 VIAL, PATENT DELIVERY SYSTEM in 1 POUCH (51662-1457-2) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, PATENT DELIVERY SYSTEM

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": "51662-1457_132cd9f9-a36c-4e35-e063-6294a90aaa17",
  "productndc": "51662-1457",
  "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 HCI",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075853",
  "marketing_category": "ANDA",
  "nonproprietary_name": "DILTIAZEM HCI",
  "start_marketing_date": "20191215",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code C05AE03.

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