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United States · US · US:65841-639_9b43fd1a-165d-420e-ba4f-f7bfaea4c283

divalproex sodium

Orange BookUNIISPL

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

Identification

ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6584163901
    100 CAPSULE, COATED PELLETS in 1 BOTTLE (65841-639-01)
  • ndc11
    6584163910
    1000 CAPSULE, COATED PELLETS in 1 BOTTLE (65841-639-10)
  • ndc11
    6584163930
    10 BLISTER PACK in 1 CARTON (65841-639-30) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
644VL95AO6
DIVALPROEX SODIUM
RxCUI 266856
Orange Book
A078919
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": "65841-639_9b43fd1a-165d-420e-ba4f-f7bfaea4c283",
  "productndc": "65841-639",
  "dosage_form": "CAPSULE, COATED PELLETS",
  "orange_book": {
    "appl_no": "078919",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 125MG VALPROIC ACID",
        "product_no": "001",
        "approval_date": "Jan 27, 2009"
      }
    ],
    "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": "ANDA078919",
  "marketing_category": "ANDA",
  "nonproprietary_name": "divalproex sodium",
  "start_marketing_date": "20090127",
  "active_numerator_strength": "125"
}

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