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United States· US:60687-217_18597a1d-035b-fba0-e063-6294a90abecf

Diltiazem Hydrochloride

A diltiazem product containing diltiazem hydrochloride, registered in United States by American Health Packaging. The same ATC class is registered in 3 of our 19 countries.

In shortageATC C05AE03Orange BookUS label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedDiltiazem HydrochlorideATCC05AE03REGISTER NO.US:60687-217_18597a1d…PACKS LISTED1CHECKEDSeptember 12, 2026

Where it is registered

Diltiazem is registered in 3 of 19 countries.

Countries holding a registration under ATC C05AE03 (diltiazem), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 3 of them publish a price we can compare per daily dose

Diltiazem · ATC C05AE03

3 / 19 countries

  • Italyprice
  • Norwayprice
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
Diltiazem Hydrochloride
Manufacturer
American Health Packaging
Country
United States (US)
ATC code
C05AE03
ATC class
Diltiazem
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 12, 2026

Packs & prices · 1

  • ndc11
    6068721701
    100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-217-01) / 1 CAPSULE, COATED, EXTENDED RELEASE in 1 BLISTER PACK (60687-217-11)

Regulatory notes

UNII (FDA substance ID)
OLH94387TE
DILTIAZEM HYDROCHLORIDE
RxCUI 203211
Orange Book
A074984
AB3AB3AB3AB3
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Diltiazem Hydrochloride Injection

Same medicine, other countries

Diltiazem in 15 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All diltiazem products

Authorised across Europe · EMA

The same active substance is authorised in 28 EEA countries. Names it is sold under:

  • Austria · Diltiazem Ratiopharm, Diltiazem Retard G.L
  • Belgium · Diltiazem Retard Eg, Progor
  • Bulgaria · Алдизем, Дилтиазем Софарма
  • Cyprus · Denazox, Diazem
  • Czechia · Diacordin Retard
  • Germany · Diltiazem Abz, Diltiazem Ethypharm
  • Denmark · Cardil
  • Estonia · Diltiazem Lannacher
  • Spain · Angiodrox, Carreldon Retard
  • Finland · Dilzem
  • France · Bi Tildiem L.P., Chlorhydrate De Diltiazem Viatris
  • United Kingdom (Northern Ireland) · Adizem-Sr, Adizem-Xl
  • Greece · Dipen, Elvesil
  • Croatia · Aldizem
  • Hungary · Blocalcin
  • Ireland · Adizem-Sr, Adizem-Xl
  • Iceland · Cardil
  • Italy · Altiazem, Diladel
  • Lithuania · Diltiazem Lannacher
  • Luxembourg · Diltiazem Retard Eg, Progor
  • Latvia · Diltiazem Lannacher
  • Malta · Denazox, Diazem
  • Netherlands · Diltiazem Aurobindo, Diltiazem Hcl Retard Mylan
  • Poland · Dilzem Retard
  • Portugal · Anatop, Anotrit
  • Romania · Diltiazem Arena, Diltiazem Eipico
  • Slovenia · Aldizem
  • Slovakia · Diacordin Retard

Source: European Medicines Agency, Article 57 product data.

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/de2e27fa-293e-4f08-9c83-d3b433dd4a70
GET /v1/drugs/de2e27fa-293e-4f08-9c83-d3b433dd4a70?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "unii": {
    "unii": "OLH94387TE",
    "rxcui": "203211",
    "inchikey": "HDRXZJPWHTXQRI-BHDTVMLSSA-N",
    "display_name": "DILTIAZEM HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 3
  },
  "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": "60687-217_18597a1d-035b-fba0-e063-6294a90abecf",
  "productndc": "60687-217",
  "dosage_form": "CAPSULE, COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "074984",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "120MG",
        "product_no": "001",
        "approval_date": "Dec 20, 1999"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "180MG",
        "product_no": "002",
        "approval_date": "Dec 20, 1999"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "240MG",
        "product_no": "003",
        "approval_date": "Dec 20, 1999"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "300MG",
        "product_no": "004",
        "approval_date": "Dec 20, 1999"
      }
    ],
    "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": "ANDA074984",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Diltiazem Hydrochloride",
  "start_marketing_date": "20170321",
  "active_numerator_strength": "240"
}

See everything about diltiazem.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.