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United States · US · US:80425-0316_2a9bf621-afbf-7627-e063-6294a90a77a9
Doxepin Hydrochloride
Orange BookUNIISPLATC D04AX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAdvanced Rx Pharmacy of Tennessee, LLC
CountryUS (United States)
ATC codeD04AX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11804250316130 CAPSULE in 1 BOTTLE (80425-0316-1)
- ndc11804250316260 CAPSULE in 1 BOTTLE (80425-0316-2)
- ndc11804250316390 CAPSULE in 1 BOTTLE (80425-0316-3)
Annotations
UNII (FDA Substance ID)
3U9A0FE9N5
DOXEPIN HYDROCHLORIDE
RxCUI 203179
Orange Book
A213063
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": "80425-0316_2a9bf621-afbf-7627-e063-6294a90a77a9",
"productndc": "80425-0316",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "213063",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 10MG BASE",
"product_no": "001",
"approval_date": "Jul 1, 2020"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 25MG BASE",
"product_no": "002",
"approval_date": "Jul 1, 2020"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 50MG BASE",
"product_no": "003",
"approval_date": "Jul 1, 2020"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 75MG BASE",
"product_no": "004",
"approval_date": "Jul 1, 2020"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "EQ 100MG BASE",
"product_no": "005",
"approval_date": "Jul 1, 2020"
}
],
"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": "ANDA213063",
"marketing_category": "ANDA",
"nonproprietary_name": "Doxepin Hydrochloride",
"start_marketing_date": "20230410",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code D04AX01.
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