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United States · US · US:69238-1170_0d905a6d-9f40-435d-a39a-f97ce7264b15
Doxepin Hydrochloride
Orange BookUNIISPLATC D04AX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals NY LLC
CountryUS (United States)
ATC codeD04AX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1169238117011000 CAPSULE in 1 BOTTLE (69238-1170-1)
- ndc11692381170330 CAPSULE in 1 BOTTLE (69238-1170-3)
- ndc11692381170990 CAPSULE in 1 BOTTLE (69238-1170-9)
Annotations
UNII (FDA Substance ID)
3U9A0FE9N5
DOXEPIN HYDROCHLORIDE
RxCUI 203179
Orange Book
A207482
ABABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "3U9A0FE9N5",
"rxcui": "203179",
"inchikey": null,
"display_name": "DOXEPIN HYDROCHLORIDE",
"substance_type": "mixture",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"89ed6385-cf6a-458e-81ea-c7f3fead41c5": {
"match": "brand_token",
"title": "DOXEPIN HYDROCHLORIDE CAPSULE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]",
"spl_version": "2",
"published_date": "2026-05-13"
}
},
"productid": "69238-1170_0d905a6d-9f40-435d-a39a-f97ce7264b15",
"productndc": "69238-1170",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "207482",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "001",
"approval_date": "Jun 28, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 25MG BASE",
"product_no": "002",
"approval_date": "Jun 28, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 50MG BASE",
"product_no": "003",
"approval_date": "Jun 28, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 75MG BASE",
"product_no": "004",
"approval_date": "Jun 28, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 100MG BASE",
"product_no": "005",
"approval_date": "Jun 28, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DOXEPIN HYDROCHLORIDE",
"proprietary_name": "Doxepin Hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA207482",
"marketing_category": "ANDA",
"nonproprietary_name": "Doxepin Hydrochloride",
"start_marketing_date": "20170628",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code D04AX01.
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