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United States · US · US:64380-869_1a530f38-ba87-4707-8d04-16be59ae34a6
GABAPENTIN
Orange BookUNIISPLATC N02BF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerStrides Pharma Science Limited
CountryUS (United States)
ATC codeN02BF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116438086906100 CAPSULE in 1 BOTTLE (64380-869-06)
- ndc116438086907500 CAPSULE in 1 BOTTLE (64380-869-07)
- ndc1164380869081000 CAPSULE in 1 BOTTLE (64380-869-08)
Annotations
UNII (FDA Substance ID)
6CW7F3G59X
GABAPENTIN
RxCUI 25480
Orange Book
A211314
ABABAB
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": "64380-869_1a530f38-ba87-4707-8d04-16be59ae34a6",
"productndc": "64380-869",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "211314",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "Oct 16, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "002",
"approval_date": "Oct 16, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "003",
"approval_date": "Oct 16, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GABAPENTIN",
"proprietary_name": "GABAPENTIN",
"active_ingred_unit": "mg/1",
"application_number": "ANDA211314",
"marketing_category": "ANDA",
"nonproprietary_name": "gabapentin",
"start_marketing_date": "20181017",
"active_numerator_strength": "400"
}Related drugs
Other records sharing ATC code N02BF01.
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