Desvenlafaxine

Orange BookUNIISPLATC N06AX23

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

Identification

ManufacturerAlembic Pharmaceuticals Limited

CountryUS (United States)

ATC codeN06AX23

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
4670854010
100 TABLET, EXTENDED RELEASE in 1 CARTON (46708-540-10)
ndc11
4670854017
14 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-540-17)
ndc11
4670854030
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-540-30)
ndc11
4670854031
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-540-31)
ndc11
4670854080
80 TABLET, EXTENDED RELEASE in 1 CARTON (46708-540-80)
ndc11
4670854090
90 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-540-90)
ndc11
4670854091
1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-540-91)

Annotations

UNII (FDA Substance ID)

ZB22ENF0XR

DESVENLAFAXINE SUCCINATE

RxCUI 683693

Orange Book

A204003

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": "46708-540_162ec8ed-f695-4db2-badf-4afb6b9e1cba",
  "productndc": "46708-540",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "204003",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 50MG BASE",
        "product_no": "001",
        "approval_date": "Jun 29, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "002",
        "approval_date": "Jun 29, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "003",
        "approval_date": "Sep 14, 2018"
      }
    ],
    "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": "ANDA204003",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Desvenlafaxine Succinate",
  "start_marketing_date": "20170301",
  "active_numerator_strength": "50"
}

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