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United States · US · US:70518-3431_50b26b52-095d-3033-e063-6394a90a9162

Divalproex Sodium

Orange BookUNIISPL

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

Identification

ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7051834310
    60 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70518-3431-0)
  • ndc11
    7051834312
    100 POUCH in 1 BOX (70518-3431-2) / 1 TABLET, DELAYED RELEASE in 1 POUCH (70518-3431-3)

Annotations

UNII (FDA Substance ID)
644VL95AO6
DIVALPROEX SODIUM
RxCUI 266856
Orange Book
A078597
ABABAB
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": "70518-3431_50b26b52-095d-3033-e063-6394a90a9162",
  "productndc": "70518-3431",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "078597",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 125MG VALPROIC ACID",
        "product_no": "001",
        "approval_date": "Jul 29, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 250MG VALPROIC ACID",
        "product_no": "002",
        "approval_date": "Jul 29, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 500MG VALPROIC ACID",
        "product_no": "003",
        "approval_date": "Jul 29, 2008"
      }
    ],
    "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": "ANDA078597",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Divalproex Sodium",
  "start_marketing_date": "20220603",
  "active_numerator_strength": "250"
}

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