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United States · US · US:0143-9637_4b1e2230-e7d4-470f-9ec5-99d03e80e897
Valproate Sodium
In shortageOrange BookUNIISPLATC N03AG01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeN03AG01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11014396371010 VIAL, SINGLE-DOSE in 1 TRAY (0143-9637-10) / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9637-01)
Annotations
UNII (FDA Substance ID)
5VOM6GYJ0D
VALPROATE SODIUM
RxCUI 9919
Orange Book
A078523
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": "0143-9637_4b1e2230-e7d4-470f-9ec5-99d03e80e897",
"productndc": "0143-9637",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "078523",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "EQ 100MG BASE/ML",
"product_no": "001",
"approval_date": "Feb 17, 2010"
}
],
"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": "ANDA078523",
"marketing_category": "ANDA",
"nonproprietary_name": "Valproate Sodium",
"start_marketing_date": "20130415",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code N03AG01.
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