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United States · US · US:0002-3240_aa5061b1-f237-425a-9d05-575c333dfd37
Cymbalta
Orange BookUNIISPLATC N06AX21
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEli Lilly and Company
CountryUS (United States)
ATC codeN06AX21
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 0
No packs registered.
Annotations
UNII (FDA Substance ID)
9044SC542W
DULOXETINE HYDROCHLORIDE
RxCUI 476250
Orange Book
N021427
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "9044SC542W",
"rxcui": "476250",
"inchikey": "BFFSMCNJSOPUAY-LMOVPXPDSA-N",
"display_name": "DULOXETINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba": {
"match": "brand_token",
"title": "CYMBALTA (DULOXETINE HYDROCHLORIDE) CAPSULE, DELAYED RELEASE [ELI LILLY AND COMPANY]",
"spl_version": "90",
"published_date": "2025-08-11"
}
},
"productid": "0002-3240_aa5061b1-f237-425a-9d05-575c333dfd37",
"productndc": "0002-3240",
"dosage_form": "CAPSULE, DELAYED RELEASE",
"orange_book": {
"appl_no": "021427",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 20MG BASE",
"product_no": "001",
"approval_date": "Aug 3, 2004"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 30MG BASE",
"product_no": "002",
"approval_date": "Aug 3, 2004"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 60MG BASE",
"product_no": "004",
"approval_date": "Aug 3, 2004"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DULOXETINE HYDROCHLORIDE",
"proprietary_name": "Cymbalta",
"active_ingred_unit": "mg/1",
"application_number": "NDA021427",
"marketing_category": "NDA",
"nonproprietary_name": "Duloxetine hydrochloride",
"start_marketing_date": "20040824",
"active_numerator_strength": "30"
}Related drugs
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