Divalproex sodium

Orange BookUNIISPL

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
7133525351
60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2535-1)
ndc11
7133525352
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2535-2)
ndc11
7133525353
90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2535-3)
ndc11
7133525354
100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2535-4)

Annotations

UNII (FDA Substance ID)

644VL95AO6

DIVALPROEX SODIUM

RxCUI 266856

Orange Book

A215527

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": "71335-2535_41db30e4-4563-57fd-e063-6294a90a4cfe",
  "productndc": "71335-2535",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "215527",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 250MG VALPROIC ACID",
        "product_no": "001",
        "approval_date": "Sep 26, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 500MG VALPROIC ACID",
        "product_no": "002",
        "approval_date": "Sep 26, 2023"
      }
    ],
    "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": "ANDA215527",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Divalproex sodium",
  "start_marketing_date": "20230926",
  "active_numerator_strength": "500"
}

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