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United States · US · US:71335-9719_377c5eca-9482-002a-e063-6294a90a9454

TIADYLT ER

In shortageOrange BookUNIISPLATC C05AE03

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeC05AE03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7133597191
    30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9719-1)
  • ndc11
    7133597192
    28 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9719-2)
  • ndc11
    7133597193
    90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9719-3)

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": "71335-9719_377c5eca-9482-002a-e063-6294a90a9454",
  "productndc": "71335-9719",
  "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": "120"
}

Related drugs

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