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United States · US · US:81469-492_d1c863b8-f352-47bd-82dc-74969d1073c7

divalproex sodium

Orange BookUNIISPL

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

Identification

ManufacturerFirst Nation Group, LLC
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    8146949201
    100 CAPSULE, COATED PELLETS in 1 BOTTLE (81469-492-01)
  • ndc11
    8146949210
    1000 CAPSULE, COATED PELLETS in 1 BOTTLE (81469-492-10)

Annotations

UNII (FDA Substance ID)
644VL95AO6
DIVALPROEX SODIUM
RxCUI 266856
Orange Book
A217358
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "644VL95AO6",
    "rxcui": "266856",
    "inchikey": "MSRILKIQRXUYCT-UHFFFAOYSA-M",
    "display_name": "DIVALPROEX SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "773a289b-65ed-4045-80c5-f00e28c1c079": {
      "match": "brand_token",
      "title": "DIVALPROEX SODIUM CAPSULE, COATED PELLETS [AJANTA PHARMA USA INC.]",
      "spl_version": "14",
      "published_date": "2026-06-01"
    }
  },
  "productid": "81469-492_d1c863b8-f352-47bd-82dc-74969d1073c7",
  "productndc": "81469-492",
  "dosage_form": "CAPSULE, COATED PELLETS",
  "orange_book": {
    "appl_no": "217358",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 125MG VALPROIC ACID",
        "product_no": "001",
        "approval_date": "Aug 12, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DIVALPROEX SODIUM",
  "proprietary_name": "divalproex sodium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA217358",
  "marketing_category": "ANDA",
  "nonproprietary_name": "divalproex sodium",
  "start_marketing_date": "20251110",
  "active_numerator_strength": "125"
}

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