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United States · US · US:70010-234_5096700d-3b93-70a3-e063-6294a90ad1d0
Trazodone Hydrochloride
Orange BookUNIISPLATC N06AX05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGranules Pharmaceuticals Inc.
CountryUS (United States)
ATC codeN06AX05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc117001023401100 TABLET in 1 BOTTLE (70010-234-01)
- ndc11700102340330 TABLET in 1 BOTTLE (70010-234-03)
- ndc117001023405500 TABLET in 1 BOTTLE (70010-234-05)
Annotations
UNII (FDA Substance ID)
6E8ZO8LRNM
TRAZODONE HYDROCHLORIDE
RxCUI 82112
Orange Book
A218988
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": "70010-234_5096700d-3b93-70a3-e063-6294a90ad1d0",
"productndc": "70010-234",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "218988",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "001",
"approval_date": "Aug 8, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "002",
"approval_date": "Aug 8, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "150MG",
"product_no": "003",
"approval_date": "Aug 8, 2024"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "004",
"approval_date": "Aug 8, 2024"
}
],
"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": "ANDA218988",
"marketing_category": "ANDA",
"nonproprietary_name": "Trazodone Hydrochloride",
"start_marketing_date": "20240809",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code N06AX05.
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