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United States · US · US:0009-0094_f5323eac-81d0-4096-ac15-2f25220c5c28

Xanax

Orange BookUNIISPLATC N05BA12

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

Identification

ManufacturerPHARMACIA & UPJOHN COMPANY LLC
CountryUS (United States)
ATC codeN05BA12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0009009401
    100 TABLET in 1 BOTTLE (0009-0094-01)

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": "0009-0094_f5323eac-81d0-4096-ac15-2f25220c5c28",
  "productndc": "0009-0094",
  "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": "19811016",
  "active_numerator_strength": "2"
}

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