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 · 7

ndc11
5199131201
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-312-01)
ndc11
5199131210
1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-312-10)
ndc11
5199131211
100 TABLET, EXTENDED RELEASE in 1 CARTON (51991-312-11)
ndc11
5199131214
14 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-312-14)
ndc11
5199131233
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-312-33)
ndc11
5199131280
80 TABLET, EXTENDED RELEASE in 1 CARTON (51991-312-80)
ndc11
5199131290
90 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-312-90)

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": "51991-312_34b890a1-3d88-43fb-b54b-f168ae22ebc7",
  "productndc": "51991-312",
  "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": "100"
}

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