Diazepam

Orange BookUNIISPLATC N05BA01

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

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeN05BA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 11

ndc11
5528909201
100 TABLET in 1 BOTTLE, PLASTIC (55289-092-01)
ndc11
5528909202
2 TABLET in 1 BOTTLE, PLASTIC (55289-092-02)
ndc11
5528909206
6 TABLET in 1 BOTTLE, PLASTIC (55289-092-06)
ndc11
5528909210
10 TABLET in 1 BOTTLE, PLASTIC (55289-092-10)
ndc11
5528909220
20 TABLET in 1 BOTTLE, PLASTIC (55289-092-20)
ndc11
5528909225
25 TABLET in 1 BOTTLE, PLASTIC (55289-092-25)
ndc11
5528909230
30 TABLET in 1 BOTTLE, PLASTIC (55289-092-30)
ndc11
5528909240
40 TABLET in 1 BOTTLE, PLASTIC (55289-092-40)
ndc11
5528909260
60 TABLET in 1 BOTTLE, PLASTIC (55289-092-60)
ndc11
5528909290
90 TABLET in 1 BOTTLE, PLASTIC (55289-092-90)
ndc11
5528909298
120 TABLET in 1 BOTTLE, PLASTIC (55289-092-98)

Annotations

UNII (FDA Substance ID)

Q3JTX2Q7TU

DIAZEPAM

RxCUI 3322

Orange Book

A070325

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": "55289-092_4199c273-a07c-ebb6-e063-6394a90a77a0",
  "productndc": "55289-092",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "070325",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Sep 4, 1985"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "002",
        "approval_date": "Sep 4, 1985"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "003",
        "approval_date": "Sep 4, 1985"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DIAZEPAM",
  "proprietary_name": "Diazepam",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA070325",
  "marketing_category": "ANDA",
  "nonproprietary_name": "diazepam",
  "start_marketing_date": "19850904",
  "active_numerator_strength": "10"
}

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