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United States · US · US:70518-4566_4a139303-d765-22b1-e063-6294a90aa507

Venlafaxine

Orange BookUNIISPLATC N06AX16

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

Identification

ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeN06AX16
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7051845660
    90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4566-0)

Annotations

UNII (FDA Substance ID)
7D7RX5A8MO
VENLAFAXINE HYDROCHLORIDE
RxCUI 235988
Orange Book
A215622
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": "70518-4566_4a139303-d765-22b1-e063-6294a90aa507",
  "productndc": "70518-4566",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "215622",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 37.5MG BASE",
        "product_no": "001",
        "approval_date": "Aug 30, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 75MG BASE",
        "product_no": "002",
        "approval_date": "Aug 30, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 150MG BASE",
        "product_no": "003",
        "approval_date": "Aug 30, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 225MG BASE",
        "product_no": "004",
        "approval_date": "Aug 30, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VENLAFAXINE HYDROCHLORIDE",
  "proprietary_name": "Venlafaxine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA215622",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Venlafaxine",
  "start_marketing_date": "20260204",
  "active_numerator_strength": "75"
}

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