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United States · US · US:24979-026_b08ee384-f82b-4f17-9e38-52ebc9187589

Diltiazem Hydrochloride

In shortageOrange BookUNIISPLATC C05AE03

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

Identification

ManufacturerUpsher-Smith Laboratories, LLC
CountryUS (United States)
ATC codeC05AE03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    2497902600
    42000 CAPSULE, EXTENDED RELEASE in 1 DRUM (24979-026-00)
  • ndc11
    2497902602
    500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (24979-026-02)
  • ndc11
    2497902606
    30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (24979-026-06)
  • ndc11
    2497902607
    90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (24979-026-07)

Annotations

UNII (FDA Substance ID)
OLH94387TE
DILTIAZEM HYDROCHLORIDE
RxCUI 203211
Orange Book
A205231
AB3AB3AB3AB3AB3
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": "24979-026_b08ee384-f82b-4f17-9e38-52ebc9187589",
  "productndc": "24979-026",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "205231",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "120MG",
        "product_no": "001",
        "approval_date": "Aug 30, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "180MG",
        "product_no": "002",
        "approval_date": "Aug 30, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "240MG",
        "product_no": "003",
        "approval_date": "Aug 30, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "300MG",
        "product_no": "004",
        "approval_date": "Aug 30, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "360MG",
        "product_no": "005",
        "approval_date": "Aug 30, 2018"
      }
    ],
    "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": "ANDA205231",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Diltiazem hydrochloride",
  "start_marketing_date": "20181001",
  "active_numerator_strength": "120"
}

Related drugs

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