TEMAZEPAM

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
0406996101
100 CAPSULE in 1 BOTTLE (0406-9961-01)

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": {
    "85919240-0bac-4ed9-97aa-f1aa29be7ffa": {
      "match": "brand_token",
      "title": "TEMAZEPAM CAPSULE [REMEDYREPACK INC.]",
      "spl_version": "13",
      "published_date": "2026-03-30"
    }
  },
  "productid": "0406-9961_2794b069-e886-4191-9227-2b6c5e569b19",
  "productndc": "0406-9961",
  "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": "TEMAZEPAM",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA018163",
  "marketing_category": "NDA",
  "nonproprietary_name": "temazepam",
  "start_marketing_date": "20100223",
  "active_numerator_strength": "15"
}

Related drugs

Other records sharing ATC code N05CD07.

Access this data programmatically

Query TEMAZEPAM and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs