Milnacipran Hydrochloride

Orange BookUNIISPLATC N06AX17

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

Identification

ManufacturerBreckenridge Pharmaceutical, Inc.

CountryUS (United States)

ATC codeN06AX17

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5199103706
60 TABLET in 1 BOTTLE (51991-037-06)

Annotations

UNII (FDA Substance ID)

RNZ43O5WW5

MILNACIPRAN HYDROCHLORIDE

RxCUI 30003

Orange Book

A205071

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": "51991-037_06af9883-25a1-4d2f-849c-a32e43a1324e",
  "productndc": "51991-037",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "205071",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG",
        "product_no": "001",
        "approval_date": "Jan 27, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Jan 27, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "003",
        "approval_date": "Jan 27, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "004",
        "approval_date": "Jan 27, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MILNACIPRAN HYDROCHLORIDE",
  "proprietary_name": "Milnacipran Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA205071",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Milnacipran Hydrochloride",
  "start_marketing_date": "20260319",
  "active_numerator_strength": "100"
}

Related drugs

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