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United States · US · US:0378-8130_dc5b7069-dc63-4393-bd87-2828328103b0
PRUDOXIN
Orange BookUNIIATC D04AX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeD04AX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1103788130451 TUBE in 1 CARTON (0378-8130-45) / 45 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
3U9A0FE9N5
DOXEPIN HYDROCHLORIDE
RxCUI 203179
Orange Book
N020126
AB
Raw payload (JSON)
{
"unii": {
"unii": "3U9A0FE9N5",
"rxcui": "203179",
"inchikey": null,
"display_name": "DOXEPIN HYDROCHLORIDE",
"substance_type": "mixture",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TOPICAL",
"productid": "0378-8130_dc5b7069-dc63-4393-bd87-2828328103b0",
"productndc": "0378-8130",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "020126",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "5%",
"product_no": "001",
"approval_date": "Apr 1, 1994"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DOXEPIN HYDROCHLORIDE",
"proprietary_name": "PRUDOXIN",
"active_ingred_unit": "mg/g",
"application_number": "NDA020126",
"marketing_category": "NDA",
"nonproprietary_name": "doxepin hydrochloride",
"start_marketing_date": "20180801",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code D04AX01.
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