diltiazem hydrochloride

In shortageOrange BookUNIISPLATC C05AE03

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

Identification

ManufacturerZydus Pharmaceuticals (USA) Inc.

CountryUS (United States)

ATC codeC05AE03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
6838259701
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-597-01)
ndc11
6838259705
500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-597-05)
ndc11
6838259706
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-597-06)
ndc11
6838259716
90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-597-16)
ndc11
6838259777
10 BLISTER PACK in 1 CARTON (68382-597-77) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-597-30)

Annotations

UNII (FDA Substance ID)

OLH94387TE

DILTIAZEM HYDROCHLORIDE

RxCUI 203211

Orange Book

A206534

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": "68382-597_3683dc39-602e-463a-b04a-6d066d2fe94d",
  "productndc": "68382-597",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "206534",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "120MG",
        "product_no": "001",
        "approval_date": "Aug 8, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "180MG",
        "product_no": "002",
        "approval_date": "Aug 8, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "240MG",
        "product_no": "003",
        "approval_date": "Aug 8, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "300MG",
        "product_no": "004",
        "approval_date": "Aug 8, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB3",
        "strength": "360MG",
        "product_no": "005",
        "approval_date": "Aug 8, 2017"
      }
    ],
    "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": "ANDA206534",
  "marketing_category": "ANDA",
  "nonproprietary_name": "diltiazem hydrochloride",
  "start_marketing_date": "20170928",
  "active_numerator_strength": "240"
}

Related drugs

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