OXAZEPAM

Orange BookUNIISPLATC N05BA04

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

Identification

ManufacturerLeading Pharma, LLC

CountryUS (United States)

ATC codeN05BA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6931591101
100 CAPSULE in 1 BOTTLE (69315-911-01)

Annotations

UNII (FDA Substance ID)

6GOW6DWN2A

OXAZEPAM

RxCUI 7781

Orange Book

A218261

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "6GOW6DWN2A",
    "rxcui": "7781",
    "inchikey": "ADIMAYPTOBDMTL-UHFFFAOYSA-N",
    "display_name": "OXAZEPAM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "a0d5a4c1-ec79-42e6-8e8f-ae4d144edb43": {
      "match": "brand_token",
      "title": "OXAZEPAM CAPSULE, GELATIN COATED [ACTAVIS PHARMA, INC.]",
      "spl_version": "20",
      "published_date": "2025-11-17"
    }
  },
  "productid": "69315-911_708e4237-a898-4d23-90b1-253c18301884",
  "productndc": "69315-911",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "218261",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Mar 3, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "002",
        "approval_date": "Mar 3, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "003",
        "approval_date": "Mar 3, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OXAZEPAM",
  "proprietary_name": "OXAZEPAM",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA218261",
  "marketing_category": "ANDA",
  "nonproprietary_name": "OXAZEPAM",
  "start_marketing_date": "20250709",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code N05BA04.

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