Divalproex sodium

Orange BookUNIISPL

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

Identification

ManufacturerAlembic Pharmaceuticals Limited

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
4670882110
100 BLISTER PACK in 1 CARTON (46708-821-10) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
ndc11
4670882131
100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-821-31)
ndc11
4670882191
1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-821-91)

Annotations

UNII (FDA Substance ID)

644VL95AO6

DIVALPROEX SODIUM

RxCUI 266856

Orange Book

A218793

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": "46708-821_f34c4504-5409-406e-995b-138e5f700242",
  "productndc": "46708-821",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "218793",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 125MG VALPROIC ACID",
        "product_no": "001",
        "approval_date": "Dec 19, 2024"
      }
    ],
    "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": "ANDA218793",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Divalproex sodium",
  "start_marketing_date": "20241223",
  "active_numerator_strength": "125"
}

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