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United States · US · US:24658-797_14002bad-2577-436d-91ca-ec1b80ab0c97
Doxepin Hydrochloride
Orange BookUNIISPLATC D04AX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS
CountryUS (United States)
ATC codeD04AX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc112465879701100 CAPSULE in 1 BOTTLE (24658-797-01)
- ndc112465879705500 CAPSULE in 1 BOTTLE (24658-797-05)
- ndc1124658797101000 CAPSULE in 1 BOTTLE (24658-797-10)
Annotations
UNII (FDA Substance ID)
3U9A0FE9N5
DOXEPIN HYDROCHLORIDE
RxCUI 203179
Orange Book
A210675
ABABABABAB
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": "24658-797_14002bad-2577-436d-91ca-ec1b80ab0c97",
"productndc": "24658-797",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "210675",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "001",
"approval_date": "Oct 16, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 25MG BASE",
"product_no": "002",
"approval_date": "Oct 16, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 100MG BASE",
"product_no": "003",
"approval_date": "Oct 16, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 50MG BASE",
"product_no": "004",
"approval_date": "Mar 3, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 75MG BASE",
"product_no": "005",
"approval_date": "Mar 3, 2022"
}
],
"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": "ANDA210675",
"marketing_category": "ANDA",
"nonproprietary_name": "Doxepin Hydrochloride",
"start_marketing_date": "20230314",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code D04AX01.
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