Divalproex Sodium

Orange BookUNIISPL

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

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
7161070753
60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-707-53)
ndc11
7161070760
90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-707-60)
ndc11
7161070770
120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-707-70)
ndc11
7161070780
180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-707-80)

Annotations

UNII (FDA Substance ID)

644VL95AO6

DIVALPROEX SODIUM

RxCUI 266856

Orange Book

A077567

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": "71610-707_391af5b8-2992-47ad-80dd-9b5c373f7ce4",
  "productndc": "71610-707",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "077567",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 250MG VALPROIC ACID",
        "product_no": "001",
        "approval_date": "Jan 29, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 500MG VALPROIC ACID",
        "product_no": "002",
        "approval_date": "Jan 29, 2009"
      }
    ],
    "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": "ANDA077567",
  "marketing_category": "ANDA",
  "nonproprietary_name": "divalproex sodium",
  "start_marketing_date": "20090202",
  "active_numerator_strength": "500"
}

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