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United States · US · US:63187-785_1f31e7f3-c013-4492-90ac-481c23448403
Gabapentin
Orange BookUNIISPLATC N02BF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeN02BF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc116318778500100 TABLET in 1 BOTTLE (63187-785-00)
- ndc11631877853030 TABLET in 1 BOTTLE (63187-785-30)
- ndc11631877856060 TABLET in 1 BOTTLE (63187-785-60)
- ndc116318778572120 TABLET in 1 BOTTLE (63187-785-72)
- ndc11631877859090 TABLET in 1 BOTTLE (63187-785-90)
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": "63187-785_1f31e7f3-c013-4492-90ac-481c23448403",
"productndc": "63187-785",
"dosage_form": "TABLET",
"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": "20160722",
"active_numerator_strength": "600"
}Related drugs
Other records sharing ATC code N02BF01.
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