Alprazolam

Orange BookUNIISPLATC N05BA12

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

Identification

ManufacturerActavis Pharma, Inc.

CountryUS (United States)

ATC codeN05BA12

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0228402211
100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (0228-4022-11)

Annotations

UNII (FDA Substance ID)

YU55MQ3IZY

ALPRAZOLAM

RxCUI 596

Orange Book

A078561

ABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "YU55MQ3IZY",
    "rxcui": "596",
    "inchikey": "VREFGVBLTWBCJP-UHFFFAOYSA-N",
    "display_name": "ALPRAZOLAM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "68d8b8d1-00a4-42c4-a796-90211fee1a6d": {
      "match": "brand_token",
      "title": "ALPRAZOLAM TABLET [BRYANT RANCH PREPACK]",
      "spl_version": "104",
      "published_date": "2026-05-22"
    }
  },
  "productid": "0228-4022_38c5b407-25a1-48f5-960e-87ef637b644c",
  "productndc": "0228-4022",
  "dosage_form": "TABLET, ORALLY DISINTEGRATING",
  "orange_book": {
    "appl_no": "078561",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.25MG",
        "product_no": "001",
        "approval_date": "Mar 16, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "002",
        "approval_date": "Mar 16, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "003",
        "approval_date": "Mar 16, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "004",
        "approval_date": "Mar 16, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ALPRAZOLAM",
  "proprietary_name": "Alprazolam",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078561",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Alprazolam",
  "start_marketing_date": "20100317",
  "active_numerator_strength": ".5"
}

Related drugs

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