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United States · US · US:43353-152_7e272f5a-86d5-48f5-92b5-50bc33f351b3
Temazepam
Orange BookUNIISPLATC N05CD07
Last synced from FDA National Drug Code directory (United States) on
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 · 3
- ndc11433531523030 CAPSULE in 1 BOTTLE (43353-152-30)
- ndc11433531525360 CAPSULE in 1 BOTTLE (43353-152-53)
- ndc11433531526090 CAPSULE in 1 BOTTLE (43353-152-60)
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": "43353-152_7e272f5a-86d5-48f5-92b5-50bc33f351b3",
"productndc": "43353-152",
"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": "20150325",
"active_numerator_strength": "7.5"
}Related drugs
Other records sharing ATC code N05CD07.
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