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United States · US · US:43063-970_415f6daf-09f1-78a5-e063-6294a90a9553

Diazepam

Orange BookUNIISPLATC N05BA01

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

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN05BA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 7

  • ndc11
    4306397004
    4 TABLET in 1 BOTTLE, PLASTIC (43063-970-04)
  • ndc11
    4306397006
    6 TABLET in 1 BOTTLE, PLASTIC (43063-970-06)
  • ndc11
    4306397010
    10 TABLET in 1 BOTTLE, PLASTIC (43063-970-10)
  • ndc11
    4306397015
    15 TABLET in 1 BOTTLE, PLASTIC (43063-970-15)
  • ndc11
    4306397021
    21 TABLET in 1 BOTTLE, PLASTIC (43063-970-21)
  • ndc11
    4306397030
    30 TABLET in 1 BOTTLE, PLASTIC (43063-970-30)
  • ndc11
    4306397060
    60 TABLET in 1 BOTTLE, PLASTIC (43063-970-60)

Annotations

UNII (FDA Substance ID)
Q3JTX2Q7TU
DIAZEPAM
RxCUI 3322
Orange Book
A071321
AB
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": "43063-970_415f6daf-09f1-78a5-e063-6294a90a9553",
  "productndc": "43063-970",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "071321",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Dec 10, 1986"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DIAZEPAM",
  "proprietary_name": "Diazepam",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA071321",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Diazepam",
  "start_marketing_date": "19861210",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code N05BA01.

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