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United States · US · US:80425-0502_30ca7888-edc4-b659-e063-6294a90ab232
TRAZODONE HYDROCHLORIDE
Orange BookUNIISPLATC N06AX05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAdvanced Rx of Tennessee, LLC
CountryUS (United States)
ATC codeN06AX05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11804250502130 TABLET in 1 BOTTLE (80425-0502-1)
- ndc11804250502260 TABLET in 1 BOTTLE (80425-0502-2)
- ndc11804250502390 TABLET in 1 BOTTLE (80425-0502-3)
Annotations
UNII (FDA Substance ID)
6E8ZO8LRNM
TRAZODONE HYDROCHLORIDE
RxCUI 82112
Orange Book
A204852
ABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "6E8ZO8LRNM",
"rxcui": "82112",
"inchikey": "OHHDIOKRWWOXMT-UHFFFAOYSA-N",
"display_name": "TRAZODONE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"df17cec9-ad5e-4e57-8572-c927c9b955e2": {
"match": "brand_token",
"title": "TRAZODONE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]",
"spl_version": "30",
"published_date": "2026-05-29"
}
},
"productid": "80425-0502_30ca7888-edc4-b659-e063-6294a90ab232",
"productndc": "80425-0502",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "204852",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "001",
"approval_date": "Feb 5, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "002",
"approval_date": "Feb 5, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "150MG",
"product_no": "003",
"approval_date": "Feb 5, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "004",
"approval_date": "Feb 5, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TRAZODONE HYDROCHLORIDE",
"proprietary_name": "TRAZODONE HYDROCHLORIDE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA204852",
"marketing_category": "ANDA",
"nonproprietary_name": "TRAZODONE HYDROCHLORIDE",
"start_marketing_date": "20250320",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N06AX05.
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