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United States · US · US:72205-053_97c3bda8-3dbe-4c7a-aee9-00418c11d24c
Doxepin hydrochloride
Orange BookUNIISPLATC D04AX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNovadoz Pharmaceuticals LLC
CountryUS (United States)
ATC codeD04AX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc117220505305500 TABLET in 1 BOTTLE (72205-053-05)
- ndc11722050533030 TABLET in 1 BOTTLE (72205-053-30)
- ndc117220505391100 TABLET in 1 BOTTLE (72205-053-91)
Annotations
UNII (FDA Substance ID)
3U9A0FE9N5
DOXEPIN HYDROCHLORIDE
RxCUI 203179
Orange Book
A214823
BXBX
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": "72205-053_97c3bda8-3dbe-4c7a-aee9-00418c11d24c",
"productndc": "72205-053",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "214823",
"products": [
{
"rs": false,
"rld": false,
"te_code": "BX",
"strength": "EQ 3MG BASE",
"product_no": "001",
"approval_date": "Apr 3, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "BX",
"strength": "EQ 6MG BASE",
"product_no": "002",
"approval_date": "Apr 3, 2023"
}
],
"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": "ANDA214823",
"marketing_category": "ANDA",
"nonproprietary_name": "Doxepin hydrochloride",
"start_marketing_date": "20230405",
"active_numerator_strength": "6"
}Related drugs
Other records sharing ATC code D04AX01.
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