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United States · US · US:72819-162_0e1f91fa-a035-857e-e063-6394a90a68c9
Doxepin
Orange BookUNIISPLATC D04AX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerArchis Pharma LLC
CountryUS (United States)
ATC codeD04AX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11728191620330 TABLET, FILM COATED in 1 BOTTLE (72819-162-03)
- ndc117281916210100 TABLET, FILM COATED in 1 BOTTLE (72819-162-10)
- ndc117281916211500 TABLET, FILM COATED in 1 BOTTLE (72819-162-11)
Annotations
UNII (FDA Substance ID)
3U9A0FE9N5
DOXEPIN HYDROCHLORIDE
RxCUI 203179
Orange Book
A202337
ABAB
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": "72819-162_0e1f91fa-a035-857e-e063-6394a90a68c9",
"productndc": "72819-162",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "202337",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 3MG BASE",
"product_no": "001",
"approval_date": "Jan 20, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 6MG BASE",
"product_no": "002",
"approval_date": "Jan 20, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DOXEPIN HYDROCHLORIDE",
"proprietary_name": "Doxepin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA202337",
"marketing_category": "ANDA",
"nonproprietary_name": "Doxepin",
"start_marketing_date": "20210801",
"active_numerator_strength": "6"
}Related drugs
Other records sharing ATC code D04AX01.
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