Back to search
🇺🇸

United States · US · US:0140-0004_ea505cdb-6d89-4b8c-8007-ec5a5fe920ce

Valium

Orange BookUNIISPLATC N05BA01

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

Identification

ManufacturerRoche Laboratories Inc.
CountryUS (United States)
ATC codeN05BA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0140000401
    1 BOTTLE, PLASTIC in 1 CARTON (0140-0004-01) / 100 TABLET in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
Q3JTX2Q7TU
DIAZEPAM
RxCUI 3322
Orange Book
N013263
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "Q3JTX2Q7TU",
    "rxcui": "3322",
    "inchikey": "AAOVKJBEBIDNHE-UHFFFAOYSA-N",
    "display_name": "DIAZEPAM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "554baee5-b171-4452-a50a-41a0946f956c": {
      "match": "brand_token",
      "title": "VALIUM (DIAZEPAM) TABLET [ROCHE LABORATORIES INC.]",
      "spl_version": "21",
      "published_date": "2025-12-10"
    }
  },
  "productid": "0140-0004_ea505cdb-6d89-4b8c-8007-ec5a5fe920ce",
  "productndc": "0140-0004",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "013263",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "004",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "006",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DIAZEPAM",
  "proprietary_name": "Valium",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA013263",
  "marketing_category": "NDA",
  "nonproprietary_name": "diazepam",
  "start_marketing_date": "19631115",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code N05BA01.

Access this data programmatically

Query Valium and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.