DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE

In shortageOrange BookUNIISPLATC C05AE03

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

Identification

Manufacturerdirect rx

CountryUS (United States)

ATC codeC05AE03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7218924890
90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72189-248-90)

Annotations

UNII (FDA Substance ID)

OLH94387TE

DILTIAZEM HYDROCHLORIDE

RxCUI 203211

Orange Book

N020401

AB4AB4AB4AB4AB4AB4

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": {
    "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": "72189-248_2c2871ee-eb23-78d5-e063-6294a90a2de9",
  "productndc": "72189-248",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "020401",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB4",
        "strength": "120MG",
        "product_no": "001",
        "approval_date": "Sep 11, 1995"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB4",
        "strength": "180MG",
        "product_no": "002",
        "approval_date": "Sep 11, 1995"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB4",
        "strength": "240MG",
        "product_no": "003",
        "approval_date": "Sep 11, 1995"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB4",
        "strength": "300MG",
        "product_no": "004",
        "approval_date": "Sep 11, 1995"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB4",
        "strength": "360MG",
        "product_no": "005",
        "approval_date": "Sep 11, 1995"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB4",
        "strength": "420MG",
        "product_no": "006",
        "approval_date": "Oct 16, 1998"
      }
    ],
    "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 EXTENDED RELEASE",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020401",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE",
  "start_marketing_date": "20210723",
  "active_numerator_strength": "240"
}

Related drugs

Other records sharing ATC code C05AE03.

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