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United States · US · US:0121-4675_8c4404f6-81d2-4211-b6b9-5e8d1f497dd6
VALPROIC ACID
Orange BookUNIISPLATC N03AG01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPAI Holdings, LLC dba PAI Pharma
CountryUS (United States)
ATC codeN03AG01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11012146750010 TRAY in 1 CASE (0121-4675-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4675-05)
- ndc1101214675404 TRAY in 1 CASE (0121-4675-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4675-05)
Annotations
UNII (FDA Substance ID)
614OI1Z5WI
VALPROIC ACID
RxCUI 11118
Orange Book
A075379
AA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "614OI1Z5WI",
"rxcui": "11118",
"inchikey": "NIJJYAXOARWZEE-UHFFFAOYSA-N",
"display_name": "VALPROIC ACID",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"ceb52870-76d0-4108-a1d4-ba7096fbacdd": {
"match": "brand_token",
"title": "VALPROIC ACID CAPSULE, LIQUID FILLED [BIONPHARMA INC.]",
"spl_version": "13",
"published_date": "2026-06-01"
}
},
"productid": "0121-4675_8c4404f6-81d2-4211-b6b9-5e8d1f497dd6",
"productndc": "0121-4675",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "075379",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "250MG/5ML",
"product_no": "001",
"approval_date": "Dec 15, 2000"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "VALPROIC ACID",
"proprietary_name": "VALPROIC ACID",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA075379",
"marketing_category": "ANDA",
"nonproprietary_name": "VALPROIC ACID",
"start_marketing_date": "20050411",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code N03AG01.
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