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United States · US · US:65862-523_700d09f5-99cc-492d-ab49-442f674d9c5d
Gabapentin
Orange BookUNIISPLATC N02BF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeN02BF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc116586252301100 TABLET, FILM COATED in 1 BOTTLE (65862-523-01)
- ndc116586252305500 TABLET, FILM COATED in 1 BOTTLE (65862-523-05)
- ndc1165862523262500 TABLET, FILM COATED in 1 BOTTLE (65862-523-26)
- ndc11658625239090 TABLET, FILM COATED in 1 BOTTLE (65862-523-90)
Annotations
UNII (FDA Substance ID)
6CW7F3G59X
GABAPENTIN
RxCUI 25480
Orange Book
A200651
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": "65862-523_700d09f5-99cc-492d-ab49-442f674d9c5d",
"productndc": "65862-523",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "200651",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "600MG",
"product_no": "001",
"approval_date": "Oct 6, 2011"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "800MG",
"product_no": "002",
"approval_date": "Oct 6, 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": "ANDA200651",
"marketing_category": "ANDA",
"nonproprietary_name": "Gabapentin",
"start_marketing_date": "20111006",
"active_numerator_strength": "600"
}Related drugs
Other records sharing ATC code N02BF01.
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