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United States · US · US:55154-4626_29696af7-4f76-41f7-b2b0-c766bd7b21ae

Savella

Orange BookUNIISPLATC N06AX17

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerCardinal Health 107, LLC
CountryUS (United States)
ATC codeN06AX17
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5515446268
    1920 TABLET, FILM COATED in 1 BOTTLE (55154-4626-8)

Annotations

UNII (FDA Substance ID)
RNZ43O5WW5
MILNACIPRAN HYDROCHLORIDE
RxCUI 30003
Orange Book
N022256
ABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "RNZ43O5WW5",
    "rxcui": "30003",
    "inchikey": "XNCDYJFPRPDERF-PBCQUBLHSA-N;XNCDYJFPRPDERF-NQQJLSKUSA-N",
    "display_name": "MILNACIPRAN HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "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": "55154-4626_29696af7-4f76-41f7-b2b0-c766bd7b21ae",
  "productndc": "55154-4626",
  "dosage_form": "TABLET, FILM COATED",
  "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": "MILNACIPRAN HYDROCHLORIDE",
  "proprietary_name": "Savella",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022256",
  "marketing_category": "NDA",
  "nonproprietary_name": "milnacipran hydrochloride",
  "start_marketing_date": "20090417",
  "active_numerator_strength": "50"
}

Related drugs

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