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United States · US · US:65162-649_1ec65e90-ec0e-431f-a985-d7cb39694492
Oxcarbazepine
Orange BookUNIISPLATC N03AF02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeN03AF02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11651626494810 CUP, UNIT-DOSE in 1 TRAY (65162-649-48) / 5 mL in 1 CUP, UNIT-DOSE (65162-649-43)
- ndc1165162649781 BOTTLE in 1 CARTON (65162-649-78) / 250 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
VZI5B1W380
OXCARBAZEPINE
RxCUI 32624
Orange Book
A202961
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": "65162-649_1ec65e90-ec0e-431f-a985-d7cb39694492",
"productndc": "65162-649",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "202961",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG/5ML",
"product_no": "001",
"approval_date": "Sep 17, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "OXCARBAZEPINE",
"proprietary_name": "Oxcarbazepine",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA202961",
"marketing_category": "ANDA",
"nonproprietary_name": "Oxcarbazepine",
"start_marketing_date": "20120604",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code N03AF02.
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