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United States · US · US:0228-2076_3050ee1e-c494-48ce-be40-6424e9661d87
Temazepam
Orange BookUNIISPLATC N05CD07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerActavis Pharma, Inc.
CountryUS (United States)
ATC codeN05CD07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc110228207610100 CAPSULE in 1 BOTTLE (0228-2076-10)
- ndc110228207650500 CAPSULE in 1 BOTTLE (0228-2076-50)
Annotations
UNII (FDA Substance ID)
CHB1QD2QSS
TEMAZEPAM
RxCUI 10355
Orange Book
A071620
ABAB
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": "0228-2076_3050ee1e-c494-48ce-be40-6424e9661d87",
"productndc": "0228-2076",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "071620",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "30MG",
"product_no": "001",
"approval_date": "Aug 7, 1987"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "15MG",
"product_no": "002",
"approval_date": "Aug 7, 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": "ANDA071620",
"marketing_category": "ANDA",
"nonproprietary_name": "Temazepam",
"start_marketing_date": "19900930",
"active_numerator_strength": "15"
}Related drugs
Other records sharing ATC code N05CD07.
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