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United States · US · US:0054-0400_c5148154-683f-4369-bb65-9f6f43a64e2b

Desvenlafaxine

Orange BookUNIISPLATC N06AX23

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

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
    0054040013
    30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0054-0400-13)
  • ndc11
    0054040022
    90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0054-0400-22)

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": "0054-0400_c5148154-683f-4369-bb65-9f6f43a64e2b",
  "productndc": "0054-0400",
  "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": "50"
}

Related drugs

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