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United States · US · US:52544-691_6b586f35-6eb1-488c-839e-581f695d3f07

Matzim LA

In shortageOrange BookUNIISPLATC C05AE03

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

Identification

ManufacturerActavis Pharma, Inc.
CountryUS (United States)
ATC codeC05AE03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5254469119
    90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (52544-691-19)
  • ndc11
    5254469130
    30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (52544-691-30)

Annotations

UNII (FDA Substance ID)
OLH94387TE
DILTIAZEM HYDROCHLORIDE
RxCUI 203211
Orange Book
A077686
ABABABABABAB
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": {
    "e8c8dd18-9d95-4068-9762-bec1eb1bc25c": {
      "match": "brand_token",
      "title": "MATZIM LA (DILTIAZEM HYDROCHLORIDE) TABLET, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]",
      "spl_version": "13",
      "published_date": "2025-12-08"
    }
  },
  "productid": "52544-691_6b586f35-6eb1-488c-839e-581f695d3f07",
  "productndc": "52544-691",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "077686",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "420MG",
        "product_no": "001",
        "approval_date": "Mar 15, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "360MG",
        "product_no": "002",
        "approval_date": "Mar 15, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "003",
        "approval_date": "Mar 15, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "240MG",
        "product_no": "004",
        "approval_date": "Mar 15, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "180MG",
        "product_no": "005",
        "approval_date": "Mar 15, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "120MG",
        "product_no": "006",
        "approval_date": "Mar 15, 2010"
      }
    ],
    "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": "Matzim LA",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077686",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Diltiazem Hydrochloride",
  "start_marketing_date": "20110328",
  "active_numerator_strength": "180"
}

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