Venlafaxine Hydrochloride

Orange BookUNIISPLATC N06AX16

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.

CountryUS (United States)

ATC codeN06AX16

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
4733576008
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-760-08)
ndc11
4733576018
1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-760-18)
ndc11
4733576061
10 BLISTER PACK in 1 BOX, UNIT-DOSE (47335-760-61) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
ndc11
4733576081
90 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-760-81)
ndc11
4733576083
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-760-83)
ndc11
4733576088
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-760-88)

Annotations

UNII (FDA Substance ID)

7D7RX5A8MO

VENLAFAXINE HYDROCHLORIDE

RxCUI 235988

Orange Book

A091272

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": "47335-760_dae15132-d26b-4ea9-b937-da9c282ada48",
  "productndc": "47335-760",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "091272",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 37.5MG BASE",
        "product_no": "001",
        "approval_date": "Aug 18, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 75MG BASE",
        "product_no": "002",
        "approval_date": "Aug 18, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 150MG BASE",
        "product_no": "003",
        "approval_date": "Aug 18, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 225MG BASE",
        "product_no": "004",
        "approval_date": "Jan 8, 2019"
      }
    ],
    "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": "ANDA091272",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Venlafaxine Hydrochloride",
  "start_marketing_date": "20141215",
  "active_numerator_strength": "37.5"
}

Related drugs

Other records sharing ATC code N06AX16.

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