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United States · US · US:70771-1529_2a2843b4-5867-4df6-af9a-dbe0264d6f1b
doxepin
Orange BookUNIISPLATC D04AX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeD04AX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc1170771152901000 TABLET in 1 BOTTLE (70771-1529-0)
- ndc117077115291100 TABLET in 1 BOTTLE (70771-1529-1)
- ndc11707711529330 TABLET in 1 BOTTLE (70771-1529-3)
- ndc11707711529410 BLISTER PACK in 1 CARTON (70771-1529-4) / 10 TABLET in 1 BLISTER PACK
- ndc117077115295500 TABLET in 1 BOTTLE (70771-1529-5)
- ndc11707711529990 TABLET in 1 BOTTLE (70771-1529-9)
Annotations
UNII (FDA Substance ID)
3U9A0FE9N5
DOXEPIN HYDROCHLORIDE
RxCUI 203179
Orange Book
A202761
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": "70771-1529_2a2843b4-5867-4df6-af9a-dbe0264d6f1b",
"productndc": "70771-1529",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "202761",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 3MG BASE",
"product_no": "001",
"approval_date": "Aug 16, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 6MG BASE",
"product_no": "002",
"approval_date": "Aug 16, 2023"
}
],
"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": "ANDA202761",
"marketing_category": "ANDA",
"nonproprietary_name": "doxepin",
"start_marketing_date": "20240630",
"active_numerator_strength": "6"
}Related drugs
Other records sharing ATC code D04AX01.
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