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United States · US · US:43598-106_d246190e-5b21-4979-98ca-e0345925deac

Diazepam

Orange BookUNIISPLATC N05BA01

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

Identification

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

Packs · 1

  • ndc11
    4359810610
    10 SYRINGE, GLASS in 1 CARTON (43598-106-10) / 2 mL in 1 SYRINGE, GLASS (43598-106-11)

Annotations

UNII (FDA Substance ID)
Q3JTX2Q7TU
DIAZEPAM
RxCUI 3322
Orange Book
A218422
AP
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": "INTRAMUSCULAR; INTRAVENOUS",
  "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": "43598-106_d246190e-5b21-4979-98ca-e0345925deac",
  "productndc": "43598-106",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "218422",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "10MG/2ML (5MG/ML)",
        "product_no": "001",
        "approval_date": "Jul 18, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DIAZEPAM",
  "proprietary_name": "Diazepam",
  "active_ingred_unit": "mg/2mL",
  "application_number": "ANDA218422",
  "marketing_category": "ANDA",
  "nonproprietary_name": "DIAZEPAM",
  "start_marketing_date": "20240807",
  "active_numerator_strength": "10"
}

Related drugs

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