Milnacipran Hydrochloride

Orange BookUNIISPLATC N06AX17

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

Identification

ManufacturerGlenmark Pharmaceuticals Inc., USA

CountryUS (United States)

ATC codeN06AX17

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6846276360
60 TABLET, FILM COATED in 1 BOTTLE (68462-763-60)

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": {
    "b66b1850-0d2a-41d6-b0ad-c676166394c7": {
      "match": "brand_token",
      "title": "MILNACIPRAN HYDROCHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]",
      "spl_version": "4",
      "published_date": "2026-03-26"
    }
  },
  "productid": "68462-763_97a7eb14-fa99-40e4-91c2-be5b34f5e203",
  "productndc": "68462-763",
  "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": "Milnacipran Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022256",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "milnacipran hydrochloride",
  "start_marketing_date": "20260319",
  "active_numerator_strength": "12.5"
}

Related drugs

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