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United States · US · US:71205-914_40b473bd-d806-4631-a7ff-58ccc51fd201

temazepam

Orange BookUNIISPLATC N05CD07

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeN05CD07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 6

  • ndc11
    7120591400
    100 CAPSULE in 1 BOTTLE (71205-914-00)
  • ndc11
    7120591430
    30 CAPSULE in 1 BOTTLE (71205-914-30)
  • ndc11
    7120591455
    500 CAPSULE in 1 BOTTLE (71205-914-55)
  • ndc11
    7120591460
    60 CAPSULE in 1 BOTTLE (71205-914-60)
  • ndc11
    7120591472
    120 CAPSULE in 1 BOTTLE (71205-914-72)
  • ndc11
    7120591490
    90 CAPSULE in 1 BOTTLE (71205-914-90)

Annotations

UNII (FDA Substance ID)
CHB1QD2QSS
TEMAZEPAM
RxCUI 10355
Orange Book
A071456
AB
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": "71205-914_40b473bd-d806-4631-a7ff-58ccc51fd201",
  "productndc": "71205-914",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "071456",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "001",
        "approval_date": "Apr 21, 1987"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TEMAZEPAM",
  "proprietary_name": "temazepam",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA071456",
  "marketing_category": "ANDA",
  "nonproprietary_name": "temazepam",
  "start_marketing_date": "19870421",
  "active_numerator_strength": "15"
}

Related drugs

Other records sharing ATC code N05CD07.

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