Estazolam

Orange BookUNIISPLATC N05CD04

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

Identification

ManufacturerActavis Pharma, Inc.

CountryUS (United States)

ATC codeN05CD04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0591074501
100 TABLET in 1 BOTTLE, PLASTIC (0591-0745-01)

Annotations

UNII (FDA Substance ID)

36S3EQV54C

ESTAZOLAM

RxCUI 4077

Orange Book

A074818

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "36S3EQV54C",
    "rxcui": "4077",
    "inchikey": "CDCHDCWJMGXXRH-UHFFFAOYSA-N",
    "display_name": "ESTAZOLAM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "a1e3b4bf-22e9-430a-a768-4d86ae886c9e": {
      "match": "brand_token",
      "title": "ESTAZOLAM TABLET [ACTAVIS PHARMA, INC.]",
      "spl_version": "23",
      "published_date": "2025-06-26"
    }
  },
  "productid": "0591-0745_5189e5a6-f58a-4eab-ac95-9d8011d6f3db",
  "productndc": "0591-0745",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "074818",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "001",
        "approval_date": "Aug 19, 1997"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "002",
        "approval_date": "Aug 19, 1997"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESTAZOLAM",
  "proprietary_name": "Estazolam",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA074818",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Estazolam",
  "start_marketing_date": "19971001",
  "active_numerator_strength": "2"
}

Related drugs

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