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United States · US · US:58151-455_27062ff4-9ce3-4d8a-aeae-f4468efb623a

Xanax

Orange BookUNIISPLATC N05BA12

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

Identification

ManufacturerViatris Specialty LLC
CountryUS (United States)
ATC codeN05BA12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5815145501
    100 TABLET in 1 BOTTLE (58151-455-01)

Annotations

UNII (FDA Substance ID)
YU55MQ3IZY
ALPRAZOLAM
RxCUI 596
Orange Book
N018276
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": {
    "388e249d-b9b6-44c3-9f8f-880eced0239f": {
      "match": "brand_token",
      "title": "XANAX (ALPRAZOLAM) TABLET [PHARMACIA & UPJOHN COMPANY LLC]",
      "spl_version": "30",
      "published_date": "2026-02-26"
    }
  },
  "productid": "58151-455_27062ff4-9ce3-4d8a-aeae-f4468efb623a",
  "productndc": "58151-455",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "018276",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "0.25MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "003",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "004",
        "approval_date": "Nov 27, 1985"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ALPRAZOLAM",
  "proprietary_name": "Xanax",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA018276",
  "marketing_category": "NDA",
  "nonproprietary_name": "alprazolam",
  "start_marketing_date": "20251029",
  "active_numerator_strength": "2"
}

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