Divalproex Sodium

Orange BookUNIISPL

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

Identification

ManufacturerDr. Reddy's Laboratories Ltd

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
5511153401
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-534-01)
ndc11
5511153405
500 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-534-05)
ndc11
5511153430
30 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-534-30)
ndc11
5511153460
60 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-534-60)

Annotations

UNII (FDA Substance ID)

644VL95AO6

DIVALPROEX SODIUM

RxCUI 266856

Orange Book

A090070

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": "55111-534_0d557d96-7ebb-86b3-bdd1-af0b959bc845",
  "productndc": "55111-534",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "090070",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 500MG VALPROIC ACID",
        "product_no": "001",
        "approval_date": "Mar 12, 2012"
      }
    ],
    "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": "ANDA090070",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Divalproex Sodium",
  "start_marketing_date": "20130811",
  "active_numerator_strength": "500"
}

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