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United States · US · US:59651-654_2f799120-0d08-47cd-8183-a98f0267c845

DIAZEPAM

Orange BookUNIISPLATC N05BA01

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

Identification

ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeN05BA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    5965165401
    100 TABLET in 1 BOTTLE (59651-654-01)
  • ndc11
    5965165405
    500 TABLET in 1 BOTTLE (59651-654-05)
  • ndc11
    5965165499
    1000 TABLET in 1 BOTTLE (59651-654-99)

Annotations

UNII (FDA Substance ID)
Q3JTX2Q7TU
DIAZEPAM
RxCUI 3322
Orange Book
A217843
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": {
    "7e7dd743-a87b-4ab3-b6ae-f116cd0c8b0f": {
      "match": "brand_token",
      "title": "DIAZEPAM INJECTION, SOLUTION [HOSPIRA, INC.]",
      "spl_version": "26",
      "published_date": "2026-05-25"
    }
  },
  "productid": "59651-654_2f799120-0d08-47cd-8183-a98f0267c845",
  "productndc": "59651-654",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "217843",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "Dec 14, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Dec 14, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Dec 14, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DIAZEPAM",
  "proprietary_name": "DIAZEPAM",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA217843",
  "marketing_category": "ANDA",
  "nonproprietary_name": "DIAZEPAM",
  "start_marketing_date": "20231214",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code N05BA01.

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