divalproex sodium

Orange BookUNIISPL

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

Identification

ManufacturerLifestar Pharma LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
7075644730
30 CAPSULE, COATED PELLETS in 1 BOTTLE (70756-447-30)
ndc11
7075644711
100 CAPSULE, COATED PELLETS in 1 BOTTLE (70756-447-11)
ndc11
7075644712
1000 CAPSULE, COATED PELLETS in 1 BOTTLE (70756-447-12)
ndc11
7075644751
500 CAPSULE, COATED PELLETS in 1 BOTTLE (70756-447-51)

Annotations

UNII (FDA Substance ID)

644VL95AO6

DIVALPROEX SODIUM

RxCUI 266856

Orange Book

A217358

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": "70756-447_7cdbbe7f-37c2-41c5-87c1-93882fa42865",
  "productndc": "70756-447",
  "dosage_form": "CAPSULE, COATED PELLETS",
  "orange_book": {
    "appl_no": "217358",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 125MG VALPROIC ACID",
        "product_no": "001",
        "approval_date": "Aug 12, 2025"
      }
    ],
    "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": "ANDA217358",
  "marketing_category": "ANDA",
  "nonproprietary_name": "divalproex sodium",
  "start_marketing_date": "20250812",
  "active_numerator_strength": "125"
}

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