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United States · US · US:68682-652_0e23d654-d8b9-af1c-e063-6294a90a6f14

Diazepam

Orange BookUNIISPLATC N05BA01

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

Identification

ManufacturerOceanside Pharmaceuticals
CountryUS (United States)
ATC codeN05BA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6868265220
    2 SYRINGE, PLASTIC in 1 PACKAGE (68682-652-20) / 2 mL in 1 SYRINGE, PLASTIC

Annotations

UNII (FDA Substance ID)
Q3JTX2Q7TU
DIAZEPAM
RxCUI 3322
Orange Book
N020648
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": "RECTAL",
  "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": "68682-652_0e23d654-d8b9-af1c-e063-6294a90a6f14",
  "productndc": "68682-652",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "020648",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "2.5MG/0.5ML (5MG/ML)",
        "product_no": "001",
        "approval_date": "Jul 29, 1997"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Jul 29, 1997"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "003",
        "approval_date": "Jul 29, 1997"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "15MG/3ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "004",
        "approval_date": "Jul 29, 1997"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "20MG/4ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "005",
        "approval_date": "Jul 29, 1997"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "20MG/4ML (5MG/ML)",
        "product_no": "006",
        "approval_date": "Sep 15, 2005"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG/2ML (5MG/ML)",
        "product_no": "007",
        "approval_date": "Sep 15, 2005"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DIAZEPAM",
  "proprietary_name": "Diazepam",
  "active_ingred_unit": "mg/2mL",
  "application_number": "NDA020648",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "diazepam",
  "start_marketing_date": "19970729",
  "active_numerator_strength": "10"
}

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