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United States · US · US:25021-797_bac93779-c94f-49e9-90b7-5a53739b47be

Valproate Sodium

In shortageOrange BookUNIISPLATC N03AG01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerSagent Pharmaceuticals
CountryUS (United States)
ATC codeN03AG01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    2502179705
    10 VIAL in 1 CARTON (25021-797-05) / 5 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
5VOM6GYJ0D
VALPROATE SODIUM
RxCUI 9919
Orange Book
A076295
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Valproate Sodium Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "5VOM6GYJ0D",
    "rxcui": "9919",
    "inchikey": "AEQFSUDEHCCHBT-UHFFFAOYSA-M",
    "display_name": "VALPROATE SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "8d5fc1c1-d3c0-497e-971b-6c4dba9a3fad": {
      "match": "brand_token",
      "title": "VALPROATE SODIUM INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]",
      "spl_version": "2",
      "published_date": "2025-12-15"
    }
  },
  "productid": "25021-797_bac93779-c94f-49e9-90b7-5a53739b47be",
  "productndc": "25021-797",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "076295",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 100MG BASE/ML",
        "product_no": "001",
        "approval_date": "Nov 14, 2002"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VALPROATE SODIUM",
  "shortage_reason": "Valproate Sodium Injection",
  "shortage_status": "current",
  "proprietary_name": "Valproate Sodium",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA076295",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Valproate Sodium",
  "start_marketing_date": "20241201",
  "active_numerator_strength": "100"
}

Related drugs

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