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United States · US · US:72578-182_d569143c-aee2-4e03-988d-1ef10950e7ce
doxepin
Orange BookUNIISPLATC D04AX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerViona Pharmaceuticals Inc
CountryUS (United States)
ATC codeD04AX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc117257818201100 TABLET in 1 BOTTLE (72578-182-01)
- ndc117257818205500 TABLET in 1 BOTTLE (72578-182-05)
- ndc11725781820630 TABLET in 1 BOTTLE (72578-182-06)
- ndc1172578182101000 TABLET in 1 BOTTLE (72578-182-10)
- ndc11725781821690 TABLET in 1 BOTTLE (72578-182-16)
- ndc11725781827710 BLISTER PACK in 1 CARTON (72578-182-77) / 10 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
3U9A0FE9N5
DOXEPIN HYDROCHLORIDE
RxCUI 203179
Orange Book
A202761
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": "72578-182_d569143c-aee2-4e03-988d-1ef10950e7ce",
"productndc": "72578-182",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "202761",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 3MG BASE",
"product_no": "001",
"approval_date": "Aug 16, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 6MG BASE",
"product_no": "002",
"approval_date": "Aug 16, 2023"
}
],
"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": "ANDA202761",
"marketing_category": "ANDA",
"nonproprietary_name": "doxepin",
"start_marketing_date": "20240630",
"active_numerator_strength": "6"
}Related drugs
Other records sharing ATC code D04AX01.
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