TIADYLT ER

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
6838274901
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-749-01)
ndc11
6838274905
500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-749-05)
ndc11
6838274906
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-749-06)
ndc11
6838274910
1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-749-10)
ndc11
6838274916
90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-749-16)

Annotations

UNII (FDA Substance ID)

OLH94387TE

DILTIAZEM HYDROCHLORIDE

RxCUI 203211

Orange Book

A206641

AB4AB4AB4AB4AB4AB4

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": {
    "b4b4e53e-fc99-4f34-abc2-57e4f28aff84": {
      "match": "brand_token",
      "title": "TIADYLT ER (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]",
      "spl_version": "103",
      "published_date": "2025-06-16"
    }
  },
  "productid": "68382-749_16e01600-83e9-4996-8b2b-c175d92a205a",
  "productndc": "68382-749",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "206641",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB4",
        "strength": "120MG",
        "product_no": "001",
        "approval_date": "Aug 11, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB4",
        "strength": "180MG",
        "product_no": "002",
        "approval_date": "Aug 11, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB4",
        "strength": "240MG",
        "product_no": "003",
        "approval_date": "Aug 11, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB4",
        "strength": "300MG",
        "product_no": "004",
        "approval_date": "Aug 11, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB4",
        "strength": "360MG",
        "product_no": "005",
        "approval_date": "Aug 11, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB4",
        "strength": "420MG",
        "product_no": "006",
        "approval_date": "Aug 11, 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": "TIADYLT ER",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA206641",
  "marketing_category": "ANDA",
  "nonproprietary_name": "diltiazem hydrochloride",
  "start_marketing_date": "20171108",
  "active_numerator_strength": "360"
}

Related drugs

Other records sharing ATC code C05AE03.

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