Divalproex sodium

Orange BookUNIISPL

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

Identification

ManufacturerREMEDYREPACK INC.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
7051834572
100 POUCH in 1 BOX (70518-3457-2) / 1 CAPSULE, COATED PELLETS in 1 POUCH (70518-3457-3)
ndc11
7051834574
30 CAPSULE, COATED PELLETS in 1 BLISTER PACK (70518-3457-4)

Annotations

UNII (FDA Substance ID)

644VL95AO6

DIVALPROEX SODIUM

RxCUI 266856

Orange Book

A213181

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": "70518-3457_534550de-5e54-d281-e063-6394a90a1412",
  "productndc": "70518-3457",
  "dosage_form": "CAPSULE, COATED PELLETS",
  "orange_book": {
    "appl_no": "213181",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 125MG VALPROIC ACID",
        "product_no": "001",
        "approval_date": "Mar 2, 2020"
      }
    ],
    "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": "ANDA213181",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Divalproex sodium",
  "start_marketing_date": "20230801",
  "active_numerator_strength": "125"
}

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