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United States · US · US:0228-2073_f191a7db-b292-4119-b144-b25c0555b050

Oxazepam

Orange BookUNIISPLATC N05BA04

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

Identification

ManufacturerActavis Pharma, Inc.
CountryUS (United States)
ATC codeN05BA04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0228207310
    100 CAPSULE, GELATIN COATED in 1 BOTTLE (0228-2073-10)

Annotations

UNII (FDA Substance ID)
6GOW6DWN2A
OXAZEPAM
RxCUI 7781
Orange Book
A072253
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": "0228-2073_f191a7db-b292-4119-b144-b25c0555b050",
  "productndc": "0228-2073",
  "dosage_form": "CAPSULE, GELATIN COATED",
  "orange_book": {
    "appl_no": "072253",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "001",
        "approval_date": "Apr 14, 1988"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Apr 14, 1988"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "003",
        "approval_date": "Apr 14, 1988"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OXAZEPAM",
  "proprietary_name": "Oxazepam",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA072253",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Oxazepam",
  "start_marketing_date": "20070102",
  "active_numerator_strength": "30"
}

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