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United States · US · US:71335-2804_a1efdaac-6a7a-4f99-ba57-6dee8278bc54
Doxepin Hydrochloride
Orange BookUNIISPLATC D04AX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeD04AX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11713352804160 CAPSULE in 1 BOTTLE, PLASTIC (71335-2804-1)
- ndc11713352804230 CAPSULE in 1 BOTTLE, PLASTIC (71335-2804-2)
- ndc11713352804390 CAPSULE in 1 BOTTLE, PLASTIC (71335-2804-3)
- ndc117133528044120 CAPSULE in 1 BOTTLE, PLASTIC (71335-2804-4)
Annotations
UNII (FDA Substance ID)
3U9A0FE9N5
DOXEPIN HYDROCHLORIDE
RxCUI 203179
Orange Book
A215113
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": "71335-2804_a1efdaac-6a7a-4f99-ba57-6dee8278bc54",
"productndc": "71335-2804",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "215113",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "001",
"approval_date": "Jun 24, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 25MG BASE",
"product_no": "002",
"approval_date": "Jun 24, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 50MG BASE",
"product_no": "003",
"approval_date": "Jun 24, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 75MG BASE",
"product_no": "004",
"approval_date": "Jun 24, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 100MG BASE",
"product_no": "005",
"approval_date": "Jun 24, 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": "ANDA215113",
"marketing_category": "ANDA",
"nonproprietary_name": "Doxepin Hydrochloride",
"start_marketing_date": "20220627",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code D04AX01.
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