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United States · US · US:68382-806_24cb2e4c-a9ba-4283-8396-343f6aa03121
Trazodone Hydrochloride
Orange BookUNIISPLATC N06AX05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeN06AX05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc116838280601100 TABLET in 1 BOTTLE (68382-806-01)
- ndc116838280605500 TABLET in 1 BOTTLE (68382-806-05)
- ndc11683828060630 TABLET in 1 BOTTLE (68382-806-06)
- ndc1168382806101000 TABLET in 1 BOTTLE (68382-806-10)
- ndc11683828061690 TABLET in 1 BOTTLE (68382-806-16)
- ndc11683828067710 BLISTER PACK in 1 CARTON (68382-806-77) / 10 TABLET in 1 BLISTER PACK (68382-806-30)
Annotations
UNII (FDA Substance ID)
6E8ZO8LRNM
TRAZODONE HYDROCHLORIDE
RxCUI 82112
Orange Book
A205253
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": "68382-806_24cb2e4c-a9ba-4283-8396-343f6aa03121",
"productndc": "68382-806",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "205253",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "001",
"approval_date": "Oct 10, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "002",
"approval_date": "Oct 10, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "150MG",
"product_no": "003",
"approval_date": "Oct 10, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "004",
"approval_date": "Oct 10, 2017"
}
],
"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": "ANDA205253",
"marketing_category": "ANDA",
"nonproprietary_name": "Trazodone Hydrochloride",
"start_marketing_date": "20171211",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code N06AX05.
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