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United States · US · US:52427-632_1b0762be-0db0-b997-b76b-b212a496f82c

venlafaxine

Orange BookUNIISPLATC N06AX16

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

Identification

ManufacturerAlmatica Pharma LLC
CountryUS (United States)
ATC codeN06AX16
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5242763230
    30 TABLET, EXTENDED RELEASE in 1 BOTTLE (52427-632-30)

Annotations

UNII (FDA Substance ID)
18XP3YT5NH
VENLAFAXINE BESYLATE MONOHYDRATE
RxCUI 2605948
Orange Book
N215429
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "18XP3YT5NH",
    "rxcui": "2605948",
    "inchikey": "XHPQSXIKZWZGIP-UHFFFAOYSA-N",
    "display_name": "VENLAFAXINE BESYLATE MONOHYDRATE",
    "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": "52427-632_1b0762be-0db0-b997-b76b-b212a496f82c",
  "productndc": "52427-632",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "215429",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 112.5MG BASE",
        "product_no": "001",
        "approval_date": "Jun 29, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VENLAFAXINE BESYLATE MONOHYDRATE",
  "proprietary_name": "venlafaxine",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA215429",
  "marketing_category": "NDA",
  "nonproprietary_name": "venlafaxine",
  "start_marketing_date": "20220630",
  "active_numerator_strength": "112.5"
}

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