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United States · US · US:58151-126_2319042f-5d24-42d3-9b0a-8893bed66813

Effexor

Orange BookUNIISPLATC N06AX16

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

Identification

ManufacturerViatris Specialty LLC
CountryUS (United States)
ATC codeN06AX16
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5815112677
    90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (58151-126-77)
  • ndc11
    5815112693
    30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (58151-126-93)

Annotations

UNII (FDA Substance ID)
7D7RX5A8MO
VENLAFAXINE HYDROCHLORIDE
RxCUI 235988
Orange Book
N020699
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "7D7RX5A8MO",
    "rxcui": "235988",
    "inchikey": "QYRYFNHXARDNFZ-UHFFFAOYSA-N",
    "display_name": "VENLAFAXINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "53c3e7ac-1852-4d70-d2b6-4fca819acf26": {
      "match": "brand_token",
      "title": "EFFEXOR XR (VENLAFAXINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.]",
      "spl_version": "50",
      "published_date": "2025-07-04"
    }
  },
  "productid": "58151-126_2319042f-5d24-42d3-9b0a-8893bed66813",
  "productndc": "58151-126",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "020699",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 37.5MG BASE",
        "product_no": "001",
        "approval_date": "Oct 20, 1997"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 75MG BASE",
        "product_no": "002",
        "approval_date": "Oct 20, 1997"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "003",
        "approval_date": "Oct 20, 1997"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 150MG BASE",
        "product_no": "004",
        "approval_date": "Oct 20, 1997"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VENLAFAXINE HYDROCHLORIDE",
  "proprietary_name": "Effexor",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020699",
  "marketing_category": "NDA",
  "nonproprietary_name": "VENLAFAXINE HYDROCHLORIDE",
  "start_marketing_date": "20241030",
  "active_numerator_strength": "75"
}

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