Savella

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
0456150055
1 BLISTER PACK in 1 CARTON (0456-1500-55) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

N022256

ABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": "ORAL",
  "spl_meta": {
    "8b720a1e-034b-4583-b80d-105a794cce74": {
      "match": "brand_token",
      "title": "SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]",
      "spl_version": "11",
      "published_date": "2026-01-28"
    }
  },
  "productid": "0456-1500_c8829ba6-79a8-476e-8cf1-eb30641287c1",
  "productndc": "0456-1500",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "022256",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "12.5MG",
        "product_no": "001",
        "approval_date": "Jan 14, 2009"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Jan 14, 2009"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "003",
        "approval_date": "Jan 14, 2009"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "004",
        "approval_date": "Jan 14, 2009"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Savella",
  "active_ingred_unit": null,
  "application_number": "NDA022256",
  "marketing_category": "NDA",
  "nonproprietary_name": "milnacipran hydrochloride",
  "start_marketing_date": "20090417",
  "active_numerator_strength": null
}

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