🇺🇸
United States · US · US:69102-418_2fc41672-1233-420d-be83-17165b23eea8
SUBVENITE
In shortageOrange BookUNIISPLATC N03AX09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerOWP Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN03AX09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1169102418011 BOTTLE in 1 PACKAGE (69102-418-01) / 240 mL in 1 BOTTLE
- ndc1169102418022 BOTTLE in 1 PACKAGE (69102-418-02) / 240 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
U3H27498KS
LAMOTRIGINE
RxCUI 28439
Orange Book
N218879
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Lamotrigine Tablet, Extended Release
Raw payload (JSON)
{
"unii": {
"unii": "U3H27498KS",
"rxcui": "28439",
"inchikey": "PYZRQGJRPPTADH-UHFFFAOYSA-N",
"display_name": "LAMOTRIGINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"7ad18b68-ba16-4810-9c3e-27fa970454e8": {
"match": "brand_token",
"title": "SUBVENITE (LAMOTRIGINE) TABLET SUBVENITE (LAMOTRIGINE) KIT [OWP PHARMACEUTICALS, INC.]",
"spl_version": "15",
"published_date": "2026-04-09"
}
},
"productid": "69102-418_2fc41672-1233-420d-be83-17165b23eea8",
"productndc": "69102-418",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "218879",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "10MG/ML",
"product_no": "001",
"approval_date": "Sep 16, 2025"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LAMOTRIGINE",
"shortage_reason": "Lamotrigine Tablet, Extended Release",
"shortage_status": "current",
"proprietary_name": "SUBVENITE",
"active_ingred_unit": "mg/mL",
"application_number": "NDA218879",
"marketing_category": "NDA",
"nonproprietary_name": "LAMOTRIGINE",
"start_marketing_date": "20251001",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code N03AX09.
- CAAG-LAMOTRIGINEANGITA PHARMA INC.
- CAAG-LAMOTRIGINEANGITA PHARMA INC.
- CAAG-LAMOTRIGINEANGITA PHARMA INC.
- 🇮🇹AMALESS*28 cpr dispers 25 mgAUROBINDO PHARMA ITALIA Srl
- 🇮🇹AMALESS*56 cpr dipers 100 mgAUROBINDO PHARMA ITALIA Srl
- 🇮🇹AMALESS*56 cpr dipers 50 mgAUROBINDO PHARMA ITALIA Srl
- 🇮🇹AMALESS*56 cpr dispers 200 mgAUROBINDO PHARMA ITALIA Srl
- CAAPO-LAMOTRIGINEAPOTEX INC
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