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United States · US · US:65841-705_e9f9a5e6-0454-4601-90e4-b170bb325eb6
Gabapentin
Orange BookUNIISPLATC N02BF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeN02BF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc116584170501100 TABLET, FILM COATED in 1 BOTTLE (65841-705-01)
- ndc116584170505500 TABLET, FILM COATED in 1 BOTTLE (65841-705-05)
- ndc1165841705101000 TABLET, FILM COATED in 1 BOTTLE (65841-705-10)
Annotations
UNII (FDA Substance ID)
6CW7F3G59X
GABAPENTIN
RxCUI 25480
Orange Book
A078926
AB1AB1
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": "65841-705_e9f9a5e6-0454-4601-90e4-b170bb325eb6",
"productndc": "65841-705",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "078926",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "600MG",
"product_no": "001",
"approval_date": "Feb 11, 2011"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "800MG",
"product_no": "002",
"approval_date": "Feb 11, 2011"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GABAPENTIN",
"proprietary_name": "Gabapentin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078926",
"marketing_category": "ANDA",
"nonproprietary_name": "Gabapentin",
"start_marketing_date": "20121016",
"active_numerator_strength": "600"
}Related drugs
Other records sharing ATC code N02BF01.
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