Temazepam

Orange BookUNIISPLATC N05CD07

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

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
7133597411
20 CAPSULE in 1 BOTTLE (71335-9741-1)
ndc11
7133597412
30 CAPSULE in 1 BOTTLE (71335-9741-2)
ndc11
7133597413
60 CAPSULE in 1 BOTTLE (71335-9741-3)
ndc11
7133597414
90 CAPSULE in 1 BOTTLE (71335-9741-4)
ndc11
7133597415
28 CAPSULE in 1 BOTTLE (71335-9741-5)
ndc11
7133597416
120 CAPSULE in 1 BOTTLE (71335-9741-6)
ndc11
7133597417
100 CAPSULE in 1 BOTTLE (71335-9741-7)

Annotations

UNII (FDA Substance ID)

CHB1QD2QSS

TEMAZEPAM

RxCUI 10355

Orange Book

A211542

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": "71335-9741_5fb01933-af3d-4abe-b7d0-8f410a0a6d39",
  "productndc": "71335-9741",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "211542",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "7.5MG",
        "product_no": "001",
        "approval_date": "Nov 23, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "002",
        "approval_date": "Nov 23, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "22.5MG",
        "product_no": "003",
        "approval_date": "Nov 23, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "004",
        "approval_date": "Nov 23, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TEMAZEPAM",
  "proprietary_name": "Temazepam",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211542",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Temazepam",
  "start_marketing_date": "20181127",
  "active_numerator_strength": "15"
}

Related drugs

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