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United States · US · US:68382-034_8c02c121-fe14-45f5-b2bc-b09fd377531f

venlafaxine hydrochloride

Orange BookUNIISPLATC N06AX16

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

Identification

ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeN06AX16
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6838203406
    30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-034-06)
  • ndc11
    6838203410
    1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-034-10)
  • ndc11
    6838203416
    90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-034-16)

Annotations

UNII (FDA Substance ID)
7D7RX5A8MO
VENLAFAXINE HYDROCHLORIDE
RxCUI 235988
Orange Book
A090174
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": "68382-034_8c02c121-fe14-45f5-b2bc-b09fd377531f",
  "productndc": "68382-034",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "090174",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 37.5MG BASE",
        "product_no": "001",
        "approval_date": "Apr 14, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 75MG BASE",
        "product_no": "002",
        "approval_date": "Apr 14, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 150MG BASE",
        "product_no": "003",
        "approval_date": "Apr 14, 2011"
      }
    ],
    "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": "ANDA090174",
  "marketing_category": "ANDA",
  "nonproprietary_name": "venlafaxine hydrochloride",
  "start_marketing_date": "20110601",
  "active_numerator_strength": "37.5"
}

Related drugs

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