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United States · US · US:10135-821_387ce260-7ac6-36e8-e063-6394a90a4e49

Desvenlafaxine

Orange BookUNIISPLATC N06AX23

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

Identification

ManufacturerMarlex Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN06AX23
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    1013582110
    1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-821-10)
  • ndc11
    1013582114
    14 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-821-14)
  • ndc11
    1013582130
    30 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-821-30)
  • ndc11
    1013582190
    90 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-821-90)

Annotations

UNII (FDA Substance ID)
ZB22ENF0XR
DESVENLAFAXINE SUCCINATE
RxCUI 683693
Orange Book
A204805
ABAB
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": "10135-821_387ce260-7ac6-36e8-e063-6394a90a4e49",
  "productndc": "10135-821",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "204805",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "001",
        "approval_date": "May 7, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "002",
        "approval_date": "May 7, 2019"
      }
    ],
    "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": "ANDA204805",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Desvenlafaxine",
  "start_marketing_date": "20250701",
  "active_numerator_strength": "50"
}

Related drugs

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