temazepam

Orange BookUNIISPLATC N05CD07

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

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC

CountryUS (United States)

ATC codeN05CD07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
4335326015
15 CAPSULE in 1 BOTTLE (43353-260-15)
ndc11
4335326020
20 CAPSULE in 1 BOTTLE (43353-260-20)
ndc11
4335326028
28 CAPSULE in 1 BOTTLE (43353-260-28)
ndc11
4335326030
30 CAPSULE in 1 BOTTLE (43353-260-30)
ndc11
4335326053
60 CAPSULE in 1 BOTTLE (43353-260-53)
ndc11
4335326060
90 CAPSULE in 1 BOTTLE (43353-260-60)

Annotations

UNII (FDA Substance ID)

CHB1QD2QSS

TEMAZEPAM

RxCUI 10355

Orange Book

A071457

ABABAB

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": "43353-260_ec1b0a54-5f93-45ed-bbbf-0bf3cd42ba73",
  "productndc": "43353-260",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "071457",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "001",
        "approval_date": "Apr 21, 1987"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "7.5MG",
        "product_no": "002",
        "approval_date": "Jun 22, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "22.5MG",
        "product_no": "003",
        "approval_date": "Jun 22, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TEMAZEPAM",
  "proprietary_name": "temazepam",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA071457",
  "marketing_category": "ANDA",
  "nonproprietary_name": "temazepam",
  "start_marketing_date": "19870421",
  "active_numerator_strength": "30"
}

Related drugs

Other records sharing ATC code N05CD07.

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