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United States · US · US:53451-0103_33da187f-72d1-daa5-e063-6394a90a66b1
Horizant
Orange BookUNIISPLATC N02BF
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAzurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)
CountryUS (United States)
ATC codeN02BF
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11534510103130 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53451-0103-1)
- ndc1153451010395 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (53451-0103-9)
Annotations
UNII (FDA Substance ID)
75OCL1SPBQ
GABAPENTIN ENACARBIL
RxCUI 1101333
Orange Book
N022399
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "75OCL1SPBQ",
"rxcui": "1101333",
"inchikey": "TZDUHAJSIBHXDL-UHFFFAOYSA-N",
"display_name": "GABAPENTIN ENACARBIL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"4c486fc7-c8c4-4c6c-b30c-366dabaeaadd": {
"match": "brand_token",
"title": "HORIZANT (GABAPENTIN ENACARBIL) TABLET, EXTENDED RELEASE [AZURITY PHARMACEUTICALS, INC. (FORMERLY ARBOR PHARMACEUTICALS)]",
"spl_version": "16",
"published_date": "2025-05-07"
}
},
"productid": "53451-0103_33da187f-72d1-daa5-e063-6394a90a66b1",
"productndc": "53451-0103",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "022399",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "600MG",
"product_no": "001",
"approval_date": "Apr 6, 2011"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "300MG",
"product_no": "002",
"approval_date": "Dec 13, 2011"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GABAPENTIN ENACARBIL",
"proprietary_name": "Horizant",
"active_ingred_unit": "mg/1",
"application_number": "NDA022399",
"marketing_category": "NDA",
"nonproprietary_name": "gabapentin enacarbil",
"start_marketing_date": "20130501",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code N02BF.
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