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 · 4

ndc11
7051834770
30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-3477-0)
ndc11
7051834771
30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-3477-1)
ndc11
7051834773
100 POUCH in 1 BOX (70518-3477-3) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-3477-4)
ndc11
7051834775
100 POUCH in 1 BOX (70518-3477-5) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-3477-6)

Annotations

UNII (FDA Substance ID)

644VL95AO6

DIVALPROEX SODIUM

RxCUI 266856

Orange Book

A209286

ABAB

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": "70518-3477_53467fe7-7d87-359b-e063-6394a90a5776",
  "productndc": "70518-3477",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "209286",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 250MG VALPROIC ACID",
        "product_no": "001",
        "approval_date": "Oct 18, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 500MG VALPROIC ACID",
        "product_no": "002",
        "approval_date": "Oct 18, 2019"
      }
    ],
    "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": "ANDA209286",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Divalproex sodium",
  "start_marketing_date": "20220816",
  "active_numerator_strength": "500"
}

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