Diazepam

Orange BookUNIISPLATC N05BA01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerNavinta LLC

CountryUS (United States)

ATC codeN05BA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6847580302
2 SYRINGE, PLASTIC in 1 PACKAGE (68475-803-02) / 2 mL in 1 SYRINGE, PLASTIC

Annotations

UNII (FDA Substance ID)

Q3JTX2Q7TU

DIAZEPAM

RxCUI 3322

Orange Book

A217468

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": "68475-803_84740b28-54e6-43df-8f50-063191eb1281",
  "productndc": "68475-803",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "217468",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG/0.5ML (5MG/ML)",
        "product_no": "001",
        "approval_date": "Nov 14, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG/2ML (5MG/ML)",
        "product_no": "002",
        "approval_date": "Nov 14, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG/4ML (5MG/ML)",
        "product_no": "003",
        "approval_date": "Nov 14, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DIAZEPAM",
  "proprietary_name": "Diazepam",
  "active_ingred_unit": "mg/2mL",
  "application_number": "ANDA217468",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Diazepam",
  "start_marketing_date": "20260206",
  "active_numerator_strength": "10"
}

Related drugs

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