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United States · US · US:42847-103_cd7bcf13-11a5-4866-9fd0-da073bb3a9a1
Silenor
Orange BookUNIISPLATC D04AX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCurrax Pharmaceuticals LLC
CountryUS (United States)
ATC codeD04AX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11428471030330 TABLET in 1 BLISTER PACK (42847-103-03)
- ndc114284710310100 TABLET in 1 BOTTLE (42847-103-10)
- ndc11428471033030 TABLET in 1 BOTTLE (42847-103-30)
- ndc114284710350500 TABLET in 1 BOTTLE (42847-103-50)
Annotations
UNII (FDA Substance ID)
3U9A0FE9N5
DOXEPIN HYDROCHLORIDE
RxCUI 203179
Orange Book
N022036
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": {
"1bec1223-5239-4eb6-a9e8-62444106d2c0": {
"match": "brand_token",
"title": "SILENOR (DOXEPIN HYDROCHLORIDE) TABLET [CURRAX PHARMACEUTICALS LLC]",
"spl_version": "11",
"published_date": "2026-04-24"
}
},
"productid": "42847-103_cd7bcf13-11a5-4866-9fd0-da073bb3a9a1",
"productndc": "42847-103",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "022036",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 3MG BASE",
"product_no": "001",
"approval_date": "Mar 17, 2010"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 6MG BASE",
"product_no": "002",
"approval_date": "Mar 17, 2010"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DOXEPIN HYDROCHLORIDE",
"proprietary_name": "Silenor",
"active_ingred_unit": "mg/1",
"application_number": "NDA022036",
"marketing_category": "NDA",
"nonproprietary_name": "doxepin hydrochloride",
"start_marketing_date": "20100801",
"active_numerator_strength": "3"
}Related drugs
Other records sharing ATC code D04AX01.
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