Desvenlafaxine

Orange BookUNIISPLATC N06AX23

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeN06AX23

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
0054040113
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0054-0401-13)
ndc11
0054040122
90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0054-0401-22)

Annotations

UNII (FDA Substance ID)

ZB22ENF0XR

DESVENLAFAXINE SUCCINATE

RxCUI 683693

Orange Book

A204083

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "ZB22ENF0XR",
    "rxcui": "683693",
    "inchikey": "PWPDEXVGKDEKTE-UHFFFAOYSA-N",
    "display_name": "DESVENLAFAXINE SUCCINATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "1d8889c9-9403-4b4b-8abd-7dc9a9fc1816": {
      "match": "brand_token",
      "title": "DESVENLAFAXINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]",
      "spl_version": "107",
      "published_date": "2026-05-25"
    }
  },
  "productid": "0054-0401_c5148154-683f-4369-bb65-9f6f43a64e2b",
  "productndc": "0054-0401",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "204083",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "001",
        "approval_date": "Feb 16, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "002",
        "approval_date": "Feb 16, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "003",
        "approval_date": "Feb 16, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DESVENLAFAXINE SUCCINATE",
  "proprietary_name": "Desvenlafaxine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204083",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Desvenlafaxine",
  "start_marketing_date": "20170301",
  "active_numerator_strength": "100"
}

Related drugs

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