DIAZEPAM

Orange BookUNIISPLATC N05BA01

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

Identification

ManufacturerASCLEMED USA INC.

CountryUS (United States)

ATC codeN05BA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
7642031401
100 TABLET in 1 BOTTLE (76420-314-01)
ndc11
7642031405
500 TABLET in 1 BOTTLE (76420-314-05)
ndc11
7642031410
10 TABLET in 1 BOTTLE (76420-314-10)
ndc11
7642031420
20 TABLET in 1 BOTTLE (76420-314-20)
ndc11
7642031430
30 TABLET in 1 BOTTLE (76420-314-30)
ndc11
7642031460
60 TABLET in 1 BOTTLE (76420-314-60)
ndc11
7642031490
90 TABLET in 1 BOTTLE (76420-314-90)

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": "76420-314_42708657-5977-a009-e063-6294a90a3919",
  "productndc": "76420-314",
  "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": "2"
}

Related drugs

Other records sharing ATC code N05BA01.

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