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United States · US · US:50228-523_3f2e32c6-5993-0189-e063-6294a90a0ff6
gabapentin
Orange BookUNIISPLATC N02BF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerScieGen Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN02BF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc115022852305500 TABLET in 1 BOTTLE (50228-523-05)
- ndc11502285233030 TABLET in 1 BOTTLE (50228-523-30)
- ndc11502285239090 TABLET in 1 BOTTLE (50228-523-90)
Annotations
UNII (FDA Substance ID)
6CW7F3G59X
GABAPENTIN
RxCUI 25480
Orange Book
A218491
AB2AB2
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "6CW7F3G59X",
"rxcui": "25480",
"inchikey": "UGJMXCAKCUNAIE-UHFFFAOYSA-N",
"display_name": "GABAPENTIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"798575b9-ddfa-4915-9574-626abbaf025f": {
"match": "brand_token",
"title": "GABAPENTIN CAPSULE [STRIDES PHARMA SCIENCE LIMITED]",
"spl_version": "3",
"published_date": "2026-06-02"
}
},
"productid": "50228-523_3f2e32c6-5993-0189-e063-6294a90a0ff6",
"productndc": "50228-523",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "218491",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB2",
"strength": "300MG",
"product_no": "001",
"approval_date": "Sep 19, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB2",
"strength": "600MG",
"product_no": "002",
"approval_date": "Sep 19, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GABAPENTIN",
"proprietary_name": "gabapentin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA218491",
"marketing_category": "ANDA",
"nonproprietary_name": "gabapentin",
"start_marketing_date": "20250920",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code N02BF01.
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