RESTORIL

Orange BookUNIISPLATC N05CD07

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

Identification

ManufacturerSpecGx LLC

CountryUS (United States)

ATC codeN05CD07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0406991403
30 CAPSULE in 1 BOTTLE (0406-9914-03)

Annotations

UNII (FDA Substance ID)

CHB1QD2QSS

TEMAZEPAM

RxCUI 10355

Orange Book

N018163

ABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "CHB1QD2QSS",
    "rxcui": "10355",
    "inchikey": "SEQDDYPDSLOBDC-UHFFFAOYSA-N",
    "display_name": "TEMAZEPAM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "bc56f7fd-1aaf-48ff-8aa7-d467e59e1015": {
      "match": "brand_token",
      "title": "RESTORIL (TEMAZEPAM) CAPSULE [SPECGX LLC]",
      "spl_version": "24",
      "published_date": "2024-05-17"
    }
  },
  "productid": "0406-9914_300ed63a-6bbc-4dbd-ba1d-e4eda4737e09",
  "productndc": "0406-9914",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "018163",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "7.5MG",
        "product_no": "003",
        "approval_date": "Oct 25, 1991"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "22.5MG",
        "product_no": "004",
        "approval_date": "Nov 2, 2004"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TEMAZEPAM",
  "proprietary_name": "RESTORIL",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA018163",
  "marketing_category": "NDA",
  "nonproprietary_name": "temazepam",
  "start_marketing_date": "19810227",
  "active_numerator_strength": "22.5"
}

Related drugs

Other records sharing ATC code N05CD07.

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