Temazepam

Orange BookUNIISPLATC N05CD07

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

Identification

ManufacturerAmneal Pharmaceuticals LLC

CountryUS (United States)

ATC codeN05CD07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6516258303
30 CAPSULE in 1 BOTTLE (65162-583-03)
ndc11
6516258310
100 CAPSULE in 1 BOTTLE (65162-583-10)
ndc11
6516258311
1000 CAPSULE in 1 BOTTLE (65162-583-11)
ndc11
6516258350
500 CAPSULE in 1 BOTTLE (65162-583-50)

Annotations

UNII (FDA Substance ID)

CHB1QD2QSS

TEMAZEPAM

RxCUI 10355

Orange Book

A203482

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": "65162-583_20d2675f-af6d-480c-9152-6f722fb1ea22",
  "productndc": "65162-583",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "203482",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "7.5MG",
        "product_no": "001",
        "approval_date": "May 23, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "002",
        "approval_date": "May 23, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "22.5MG",
        "product_no": "003",
        "approval_date": "May 23, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "004",
        "approval_date": "May 23, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TEMAZEPAM",
  "proprietary_name": "Temazepam",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA203482",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Temazepam",
  "start_marketing_date": "20160523",
  "active_numerator_strength": "7.5"
}

Related drugs

Other records sharing ATC code N05CD07.

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