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United States · US · US:54838-512_5408fdf5-16a7-4d5a-b4c4-2ccb271759a2
Doxepin Hydrochloride
Orange BookUNIISPLATC D04AX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLannett Company, Inc.
CountryUS (United States)
ATC codeD04AX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc115483851240120 mL in 1 BOTTLE, PLASTIC (54838-512-40)
Annotations
UNII (FDA Substance ID)
3U9A0FE9N5
DOXEPIN HYDROCHLORIDE
RxCUI 203179
Orange Book
A074721
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": "54838-512_5408fdf5-16a7-4d5a-b4c4-2ccb271759a2",
"productndc": "54838-512",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "074721",
"products": [
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "EQ 10MG BASE/ML",
"product_no": "001",
"approval_date": "Dec 29, 1998"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DOXEPIN HYDROCHLORIDE",
"proprietary_name": "Doxepin Hydrochloride",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA074721",
"marketing_category": "ANDA",
"nonproprietary_name": "Doxepin Hydrochloride",
"start_marketing_date": "19981229",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code D04AX01.
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