VENLAFAXINE HYDROCHLORIDE

Orange BookUNIISPLATC N06AX16

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

Identification

ManufacturerMarlex Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeN06AX16

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
1013582510
1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10135-825-10)
ndc11
1013582530
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10135-825-30)
ndc11
1013582575
15 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10135-825-75)
ndc11
1013582590
90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10135-825-90)

Annotations

UNII (FDA Substance ID)

7D7RX5A8MO

VENLAFAXINE HYDROCHLORIDE

RxCUI 235988

Orange Book

A201272

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": {
    "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": "10135-825_3d59e057-318b-f098-e063-6394a90a25be",
  "productndc": "10135-825",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "201272",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 37.5MG BASE",
        "product_no": "001",
        "approval_date": "Nov 23, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 75MG BASE",
        "product_no": "002",
        "approval_date": "Nov 23, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 150MG BASE",
        "product_no": "003",
        "approval_date": "Nov 23, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VENLAFAXINE HYDROCHLORIDE",
  "proprietary_name": "VENLAFAXINE HYDROCHLORIDE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA201272",
  "marketing_category": "ANDA",
  "nonproprietary_name": "VENLAFAXINE HYDROCHLORIDE",
  "start_marketing_date": "20250801",
  "active_numerator_strength": "37.5"
}

Related drugs

Other records sharing ATC code N06AX16.

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