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United States · US · US:10135-798_38688247-8bdb-ee98-e063-6294a90a8ef6
Oxcarbazepine
Orange BookUNIISPLATC N03AF02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMarlex Pharmaceuticals, Inc
CountryUS (United States)
ATC codeN03AF02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc111013579841250 mL in 1 BOTTLE, GLASS (10135-798-41)
Annotations
UNII (FDA Substance ID)
VZI5B1W380
OXCARBAZEPINE
RxCUI 32624
Orange Book
A217782
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "VZI5B1W380",
"rxcui": "32624",
"inchikey": "CTRLABGOLIVAIY-UHFFFAOYSA-N",
"display_name": "OXCARBAZEPINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"a18f591b-587e-4769-8ac2-9cfba0b82526": {
"match": "brand_token",
"title": "OXCARBAZEPINE (OXCARBAZEPINE) SUSPENSION [CAMBER PHARMACEUTICALS, INC.]",
"spl_version": "3",
"published_date": "2026-05-25"
}
},
"productid": "10135-798_38688247-8bdb-ee98-e063-6294a90a8ef6",
"productndc": "10135-798",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "217782",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG/5ML",
"product_no": "001",
"approval_date": "Feb 14, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "OXCARBAZEPINE",
"proprietary_name": "Oxcarbazepine",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA217782",
"marketing_category": "ANDA",
"nonproprietary_name": "Oxcarbazepine",
"start_marketing_date": "20250501",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code N03AF02.
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