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United States · US · US:63629-1619_ca9c9c3f-cf46-4b88-9b14-58bc48ed1d5f

temazepam

Orange BookUNIISPLATC N05CD07

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeN05CD07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 7

  • ndc11
    6362916191
    20 CAPSULE in 1 BOTTLE (63629-1619-1)
  • ndc11
    6362916192
    30 CAPSULE in 1 BOTTLE (63629-1619-2)
  • ndc11
    6362916193
    60 CAPSULE in 1 BOTTLE (63629-1619-3)
  • ndc11
    6362916194
    90 CAPSULE in 1 BOTTLE (63629-1619-4)
  • ndc11
    6362916195
    28 CAPSULE in 1 BOTTLE (63629-1619-5)
  • ndc11
    6362916196
    120 CAPSULE in 1 BOTTLE (63629-1619-6)
  • ndc11
    6362916197
    100 CAPSULE in 1 BOTTLE (63629-1619-7)

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": "63629-1619_ca9c9c3f-cf46-4b88-9b14-58bc48ed1d5f",
  "productndc": "63629-1619",
  "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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