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United States · US · US:63629-1621_08939dce-f4c7-454f-8ae7-40d6fe90312c

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 · 9

  • ndc11
    6362916211
    30 CAPSULE in 1 BOTTLE (63629-1621-1)
  • ndc11
    6362916212
    20 CAPSULE in 1 BOTTLE (63629-1621-2)
  • ndc11
    6362916213
    100 CAPSULE in 1 BOTTLE (63629-1621-3)
  • ndc11
    6362916214
    60 CAPSULE in 1 BOTTLE (63629-1621-4)
  • ndc11
    6362916215
    90 CAPSULE in 1 BOTTLE (63629-1621-5)
  • ndc11
    6362916216
    28 CAPSULE in 1 BOTTLE (63629-1621-6)
  • ndc11
    6362916217
    10 CAPSULE in 1 BOTTLE (63629-1621-7)
  • ndc11
    6362916218
    45 CAPSULE in 1 BOTTLE (63629-1621-8)
  • ndc11
    6362916219
    120 CAPSULE in 1 BOTTLE (63629-1621-9)

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": "63629-1621_08939dce-f4c7-454f-8ae7-40d6fe90312c",
  "productndc": "63629-1621",
  "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

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