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United States · US · US:33342-389_edf18b33-a226-44f8-9f42-c409e691ee64

Desvenlafaxine Succinate

Orange BookUNIISPLATC N06AX23

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

Identification

ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC codeN06AX23
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    3334238907
    30 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-389-07)
  • ndc11
    3334238910
    90 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-389-10)
  • ndc11
    3334238912
    10 BLISTER PACK in 1 CARTON (33342-389-12) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
ZB22ENF0XR
DESVENLAFAXINE SUCCINATE
RxCUI 683693
Orange Book
A211427
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": "33342-389_edf18b33-a226-44f8-9f42-c409e691ee64",
  "productndc": "33342-389",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "211427",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "001",
        "approval_date": "Jan 15, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "002",
        "approval_date": "Jan 15, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DESVENLAFAXINE SUCCINATE",
  "proprietary_name": "Desvenlafaxine Succinate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211427",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Desvenlafaxine Succinate",
  "start_marketing_date": "20180616",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code N06AX23.

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