Diltiazem Hydrochloride

In shortageOrange BookUNIISPLATC C05AE03

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeC05AE03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6318776910
10 TABLET, FILM COATED in 1 BOTTLE (63187-769-10)
ndc11
6318776930
30 TABLET, FILM COATED in 1 BOTTLE (63187-769-30)
ndc11
6318776960
60 TABLET, FILM COATED in 1 BOTTLE (63187-769-60)
ndc11
6318776990
90 TABLET, FILM COATED in 1 BOTTLE (63187-769-90)

Annotations

UNII (FDA Substance ID)

OLH94387TE

DILTIAZEM HYDROCHLORIDE

RxCUI 203211

Orange Book

A074185

ABABABAB

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": "63187-769_8cfc7ee8-ec1c-478b-bd90-6778f9c3fb98",
  "productndc": "63187-769",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "074185",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "001",
        "approval_date": "May 31, 1995"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "002",
        "approval_date": "May 31, 1995"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "90MG",
        "product_no": "003",
        "approval_date": "May 31, 1995"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "120MG",
        "product_no": "004",
        "approval_date": "May 31, 1995"
      }
    ],
    "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": "ANDA074185",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Diltiazem Hydrochloride",
  "start_marketing_date": "19951226",
  "active_numerator_strength": "120"
}

Related drugs

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