Diltiazem Hydrochloride

In shortageOrange BookUNIISPLATC C05AE03

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.

CountryUS (United States)

ATC codeC05AE03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
4733567813
500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-678-13)
ndc11
4733567818
1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-678-18)
ndc11
4733567819
90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-678-19)
ndc11
4733567881
90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-678-81)
ndc11
4733567883
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-678-83)

Annotations

UNII (FDA Substance ID)

OLH94387TE

DILTIAZEM HYDROCHLORIDE

RxCUI 203211

Orange Book

A090492

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": "47335-678_3c94f868-93d3-4b36-8420-b2903a0bd79a",
  "productndc": "47335-678",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "090492",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "120MG",
        "product_no": "001",
        "approval_date": "Oct 28, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "180MG",
        "product_no": "002",
        "approval_date": "Oct 28, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "240MG",
        "product_no": "003",
        "approval_date": "Oct 28, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "300MG",
        "product_no": "004",
        "approval_date": "Oct 28, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "360MG",
        "product_no": "005",
        "approval_date": "Oct 28, 2011"
      }
    ],
    "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": "ANDA090492",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Diltiazem Hydrochloride",
  "start_marketing_date": "20111031",
  "active_numerator_strength": "300"
}

Related drugs

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