Divalproex Sodium

Orange BookUNIISPL

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

Identification

ManufacturerMajor Pharmaceuticals

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
0904636345
80 BLISTER PACK in 1 CARTON (0904-6363-45) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
ndc11
0904636361
100 BLISTER PACK in 1 CARTON (0904-6363-61) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

644VL95AO6

DIVALPROEX SODIUM

RxCUI 266856

Orange Book

A090161

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": "0904-6363_7b77fe8c-7100-4756-90ce-0dba2543d9e4",
  "productndc": "0904-6363",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "090161",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 250MG VALPROIC ACID",
        "product_no": "001",
        "approval_date": "Mar 15, 2012"
      }
    ],
    "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": "ANDA090161",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Divalproex Sodium",
  "start_marketing_date": "20130811",
  "active_numerator_strength": "250"
}

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