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United States · US · US:76282-405_20a38b18-352b-47a6-b640-091b42db10aa
GABAPENTIN
Orange BookUNIISPLATC N02BF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerExelan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeN02BF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc117628240501100 TABLET, FILM COATED in 1 BOTTLE (76282-405-01)
- ndc117628240505500 TABLET, FILM COATED in 1 BOTTLE (76282-405-05)
- ndc11762824053030 TABLET, FILM COATED in 1 BOTTLE (76282-405-30)
- ndc11762824059090 TABLET, FILM COATED in 1 BOTTLE (76282-405-90)
Annotations
UNII (FDA Substance ID)
6CW7F3G59X
GABAPENTIN
RxCUI 25480
Orange Book
A202764
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": "76282-405_20a38b18-352b-47a6-b640-091b42db10aa",
"productndc": "76282-405",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "202764",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "600MG",
"product_no": "001",
"approval_date": "Oct 16, 2012"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "800MG",
"product_no": "002",
"approval_date": "Oct 16, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GABAPENTIN",
"proprietary_name": "GABAPENTIN",
"active_ingred_unit": "mg/1",
"application_number": "ANDA202764",
"marketing_category": "ANDA",
"nonproprietary_name": "gabapentin",
"start_marketing_date": "20121102",
"active_numerator_strength": "600"
}Related drugs
Other records sharing ATC code N02BF01.
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