SUBVENITE

Orange BookSPL

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

Identification

ManufacturerOWP Pharmaceuticals, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6910230601
35 BLISTER PACK in 1 BLISTER PACK (69102-306-01) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

A078947

ABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "7ad18b68-ba16-4810-9c3e-27fa970454e8": {
      "match": "brand_token",
      "title": "SUBVENITE (LAMOTRIGINE) TABLET SUBVENITE (LAMOTRIGINE) KIT [OWP PHARMACEUTICALS, INC.]",
      "spl_version": "15",
      "published_date": "2026-04-09"
    }
  },
  "productid": "69102-306_15cf4680-04a8-421c-a475-cd753b58b604",
  "productndc": "69102-306",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "078947",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Jan 27, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Jan 27, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "003",
        "approval_date": "Jan 27, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "004",
        "approval_date": "Jan 27, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "SUBVENITE",
  "active_ingred_unit": null,
  "application_number": "ANDA078947",
  "marketing_category": "ANDA",
  "nonproprietary_name": "LAMOTRIGINE",
  "start_marketing_date": "20180414",
  "active_numerator_strength": null
}

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