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United States· US:65162-755_eafef6af-5c62-46de-a556-b83d554b2a5f

Divalproex Sodium

A medicinal product containing divalproex sodium, registered in United States by Amneal Pharmaceuticals LLC.

Orange BookUS label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedDivalproex SodiumATC—REGISTER NO.US:65162-755_eafef6af…PACKS LISTED2CHECKEDJune 3, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
Divalproex Sodium
Manufacturer
Amneal Pharmaceuticals LLC
Country
United States (US)
ATC code
—
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
June 3, 2026

Packs & prices · 2

  • ndc11
    6516275510
    100 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-755-10)
  • ndc11
    6516275550
    500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-755-50)

Regulatory notes

UNII (FDA substance ID)
644VL95AO6
DIVALPROEX SODIUM
RxCUI 266856
Orange Book
A203730
ABAB
DailyMed SPL labels
1 version tracked

Same medicine, other countries

Divalproex sodium in 1 other country

What each register calls a product with the same active substance — salts and hydrates count as the same.

All divalproex sodium products

Authorised across Europe · EMA

The same active substance is authorised in 5 EEA countries. Names it is sold under:

  • France · Depakote, Divalcote
  • United Kingdom (Northern Ireland) · Belvo, Depakote
  • Croatia · Dipleksil
  • Portugal · Diplexil-R, Valproato Semisódico Tecnifar
  • Slovenia · Dipleksil

Source: European Medicines Agency, Article 57 product data.

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/b6085038-755e-4d8a-b3a6-7ce08540a97f
GET /v1/drugs/b6085038-755e-4d8a-b3a6-7ce08540a97f?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "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": "65162-755_eafef6af-5c62-46de-a556-b83d554b2a5f",
  "productndc": "65162-755",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "203730",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 250MG VALPROIC ACID",
        "product_no": "001",
        "approval_date": "May 29, 2015"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 500MG VALPROIC ACID",
        "product_no": "002",
        "approval_date": "May 29, 2015"
      }
    ],
    "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": "ANDA203730",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Divalproex Sodium",
  "start_marketing_date": "20150601",
  "active_numerator_strength": "250"
}

See everything about divalproex sodium.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.