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United States · US · US:69315-163_ab05177e-b4a4-4cc5-b950-441858aaa0ca
DOXEPIN HYDROCHLORIDE
Orange BookUNIISPLATC D04AX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLeading Pharma, LLC
CountryUS (United States)
ATC codeD04AX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116931516301100 CAPSULE in 1 PACKAGE (69315-163-01)
- ndc116931516305500 CAPSULE in 1 PACKAGE (69315-163-05)
- ndc11693151635050 CAPSULE in 1 PACKAGE (69315-163-50)
Annotations
UNII (FDA Substance ID)
3U9A0FE9N5
DOXEPIN HYDROCHLORIDE
RxCUI 203179
Orange Book
A211618
AB
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": "69315-163_ab05177e-b4a4-4cc5-b950-441858aaa0ca",
"productndc": "69315-163",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "211618",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 150MG BASE",
"product_no": "001",
"approval_date": "Mar 1, 2021"
}
],
"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": "ANDA211618",
"marketing_category": "ANDA",
"nonproprietary_name": "DOXEPIN HYDROCHLORIDE",
"start_marketing_date": "20210415",
"active_numerator_strength": "150"
}Related drugs
Other records sharing ATC code D04AX01.
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