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United States · US · US:0456-2212_b4f9c587-d1eb-462b-bad2-ed0ce6d76c57
Fetzima
Orange BookUNIISPLATC N06AX28
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAllergan, Inc.
CountryUS (United States)
ATC codeN06AX28
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11045622123030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0456-2212-30)
- ndc11045622129090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0456-2212-90)
Annotations
UNII (FDA Substance ID)
371U2ZK31U
LEVOMILNACIPRAN HYDROCHLORIDE
RxCUI 1433211
Orange Book
N204168
ABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "371U2ZK31U",
"rxcui": "1433211",
"inchikey": "XNCDYJFPRPDERF-NQQJLSKUSA-N",
"display_name": "LEVOMILNACIPRAN HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"f371258d-91b3-4b6a-ac99-434a1964c3af": {
"match": "brand_token",
"title": "FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE FETZIMA (LEVOMILNACIPRAN HYDROCHLORIDE) KIT [ALLERGAN, INC.]",
"spl_version": "33",
"published_date": "2026-02-23"
}
},
"productid": "0456-2212_b4f9c587-d1eb-462b-bad2-ed0ce6d76c57",
"productndc": "0456-2212",
"dosage_form": "CAPSULE, EXTENDED RELEASE",
"orange_book": {
"appl_no": "204168",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 20MG BASE",
"product_no": "001",
"approval_date": "Jul 25, 2013"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 40MG BASE",
"product_no": "002",
"approval_date": "Jul 25, 2013"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "EQ 80MG BASE",
"product_no": "003",
"approval_date": "Jul 25, 2013"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "EQ 120MG BASE",
"product_no": "004",
"approval_date": "Jul 25, 2013"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEVOMILNACIPRAN HYDROCHLORIDE",
"proprietary_name": "Fetzima",
"active_ingred_unit": "mg/1",
"application_number": "NDA204168",
"marketing_category": "NDA",
"nonproprietary_name": "LEVOMILNACIPRAN HYDROCHLORIDE",
"start_marketing_date": "20130725",
"active_numerator_strength": "120"
}Related drugs
Other records sharing ATC code N06AX28.
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