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United States · US · US:70518-3971_4bd38707-fb4d-58c2-e063-6394a90a3c51

Venlafaxine Hydrochloride

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
    7051839710
    30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70518-3971-0)

Annotations

UNII (FDA Substance ID)
7D7RX5A8MO
VENLAFAXINE HYDROCHLORIDE
RxCUI 235988
Orange Book
A214654
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": "70518-3971_4bd38707-fb4d-58c2-e063-6394a90a3c51",
  "productndc": "70518-3971",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "214654",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 37.5MG BASE",
        "product_no": "001",
        "approval_date": "Aug 6, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 75MG BASE",
        "product_no": "002",
        "approval_date": "Aug 6, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 150MG BASE",
        "product_no": "003",
        "approval_date": "Aug 6, 2021"
      }
    ],
    "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": "ANDA214654",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Venlafaxine Hydrochloride",
  "start_marketing_date": "20231227",
  "active_numerator_strength": "37.5"
}

Related drugs

Other records sharing ATC code N06AX16.

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