🇺🇸
United States · US · US:0093-9609_7d22a419-3d33-492c-b054-fb29a82ce643
doxepin hydrochloride
Orange BookUNIISPLATC D04AX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTeva Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeD04AX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1100939609951 TUBE in 1 CARTON (0093-9609-95) / 45 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
3U9A0FE9N5
DOXEPIN HYDROCHLORIDE
RxCUI 203179
Orange Book
A215408
AB
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": "TOPICAL",
"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": "0093-9609_7d22a419-3d33-492c-b054-fb29a82ce643",
"productndc": "0093-9609",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "215408",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5%",
"product_no": "001",
"approval_date": "Feb 17, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DOXEPIN HYDROCHLORIDE",
"proprietary_name": "doxepin hydrochloride",
"active_ingred_unit": "mg/g",
"application_number": "ANDA215408",
"marketing_category": "ANDA",
"nonproprietary_name": "doxepin hydrochloride",
"start_marketing_date": "20230217",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code D04AX01.
Access this data programmatically
Query doxepin hydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.