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United States · US · US:64380-203_b6b0f575-6e3a-4011-b33f-a051103058c2
Doxepin
Orange BookUNIISPLATC D04AX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerStrides Pharma Science Limited
CountryUS (United States)
ATC codeD04AX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11643802030130 TABLET in 1 BOTTLE, PLASTIC (64380-203-01)
- ndc116438020302100 TABLET in 1 BOTTLE, PLASTIC (64380-203-02)
- ndc116438020303500 TABLET in 1 BOTTLE, PLASTIC (64380-203-03)
Annotations
UNII (FDA Substance ID)
3U9A0FE9N5
DOXEPIN HYDROCHLORIDE
RxCUI 203179
Orange Book
A202510
ABAB
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": "64380-203_b6b0f575-6e3a-4011-b33f-a051103058c2",
"productndc": "64380-203",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "202510",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 3MG BASE",
"product_no": "001",
"approval_date": "Jul 24, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 6MG BASE",
"product_no": "002",
"approval_date": "Jul 24, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DOXEPIN HYDROCHLORIDE",
"proprietary_name": "Doxepin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA202510",
"marketing_category": "ANDA",
"nonproprietary_name": "doxepin hydrochloride",
"start_marketing_date": "20220912",
"active_numerator_strength": "3"
}Related drugs
Other records sharing ATC code D04AX01.
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