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United States · US · US:42799-963_a7958920-40c7-4038-8524-3f830555d345

venlafaxine hydrochloride, extended release

Orange BookUNIISPLATC N06AX16

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

Identification

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

Packs · 2

  • ndc11
    4279996301
    30 TABLET in 1 BOTTLE (42799-963-01)
  • ndc11
    4279996302
    90 TABLET in 1 BOTTLE (42799-963-02)

Annotations

UNII (FDA Substance ID)
7D7RX5A8MO
VENLAFAXINE HYDROCHLORIDE
RxCUI 235988
Orange Book
A209193
ABAB
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": "42799-963_a7958920-40c7-4038-8524-3f830555d345",
  "productndc": "42799-963",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "209193",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 150MG BASE",
        "product_no": "001",
        "approval_date": "Oct 31, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 225MG BASE",
        "product_no": "002",
        "approval_date": "Oct 31, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VENLAFAXINE HYDROCHLORIDE",
  "proprietary_name": "venlafaxine hydrochloride, extended release",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209193",
  "marketing_category": "ANDA",
  "nonproprietary_name": "venlafaxine hydrochloride, extended release",
  "start_marketing_date": "20230315",
  "active_numerator_strength": "225"
}

Related drugs

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