Diltiazem Hydrochloride

In shortageOrange BookSPLATC C05AE03

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeC05AE03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5009078150
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-7815-0)
ndc11
5009078151
90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-7815-1)

Annotations

Orange Book

A075116

AB3AB3AB3AB3

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Diltiazem Hydrochloride Injection

Raw payload (JSON)

{
  "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": "50090-7815_00b16eac-2719-4dfb-b1bc-3f92e0ac930c",
  "productndc": "50090-7815",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "075116",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "120MG",
        "product_no": "001",
        "approval_date": "Dec 23, 1999"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "180MG",
        "product_no": "002",
        "approval_date": "Dec 23, 1999"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "240MG",
        "product_no": "003",
        "approval_date": "Dec 23, 1999"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "300MG",
        "product_no": "004",
        "approval_date": "Dec 23, 1999"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DILTIAZEM HCL",
  "shortage_reason": "Diltiazem Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "Diltiazem Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075116",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Diltiazem Hydrochloride",
  "start_marketing_date": "19991228",
  "active_numerator_strength": "240"
}

Related drugs

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