Desvenlafaxine

Orange BookUNIISPLATC N06AX23

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

Identification

ManufacturerBreckenridge Pharmaceutical, Inc

CountryUS (United States)

ATC codeN06AX23

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
5199100601
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-006-01)
ndc11
5199100610
1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-006-10)
ndc11
5199100611
100 TABLET, EXTENDED RELEASE in 1 CARTON (51991-006-11)
ndc11
5199100633
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-006-33)
ndc11
5199100680
80 TABLET, EXTENDED RELEASE in 1 CARTON (51991-006-80)
ndc11
5199100690
90 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-006-90)

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": "51991-006_34b890a1-3d88-43fb-b54b-f168ae22ebc7",
  "productndc": "51991-006",
  "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": "20181128",
  "active_numerator_strength": "25"
}

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