Fetzima

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAllergan, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0456220007
1 BLISTER PACK in 1 CARTON (0456-2200-07) / 1 KIT in 1 BLISTER PACK (0456-2200-65) * 2 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0456-2220-00) * 5 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0456-2240-00)

Annotations

Orange Book

N204168

ABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "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": "0456-2200_b4f9c587-d1eb-462b-bad2-ed0ce6d76c57",
  "productndc": "0456-2200",
  "dosage_form": "KIT",
  "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": null,
  "proprietary_name": "Fetzima",
  "active_ingred_unit": null,
  "application_number": "NDA204168",
  "marketing_category": "NDA",
  "nonproprietary_name": "LEVOMILNACIPRAN HYDROCHLORIDE",
  "start_marketing_date": "20230324",
  "active_numerator_strength": null
}

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