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United States · US · US:80425-0477_2d034ebe-1e07-6fe0-e063-6394a90a368b

Venlafaxine Hydrochloride

Orange BookUNIISPLATC N06AX16

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

Identification

ManufacturerAdvanced Rx of Tennessee, LLC
CountryUS (United States)
ATC codeN06AX16
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    8042504771
    30 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0477-1)
  • ndc11
    8042504772
    60 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0477-2)
  • ndc11
    8042504773
    90 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0477-3)

Annotations

UNII (FDA Substance ID)
7D7RX5A8MO
VENLAFAXINE HYDROCHLORIDE
RxCUI 235988
Orange Book
N022104
ABABABAB
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": {
    "b865c175-e75d-4cb4-ac29-dec72226302c": {
      "match": "brand_token",
      "title": "VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [NORTHSTAR RXLLC]",
      "spl_version": "1",
      "published_date": "2026-06-02"
    }
  },
  "productid": "80425-0477_2d034ebe-1e07-6fe0-e063-6394a90a368b",
  "productndc": "80425-0477",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "022104",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 37.5MG BASE",
        "product_no": "001",
        "approval_date": "May 20, 2008"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 75MG BASE",
        "product_no": "002",
        "approval_date": "May 20, 2008"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 150MG BASE",
        "product_no": "003",
        "approval_date": "May 20, 2008"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 225MG BASE",
        "product_no": "004",
        "approval_date": "May 20, 2008"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VENLAFAXINE HYDROCHLORIDE",
  "proprietary_name": "Venlafaxine Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022104",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "venlafaxine hydrochloride",
  "start_marketing_date": "20250130",
  "active_numerator_strength": "37.5"
}

Related drugs

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