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United States · US · US:69097-812_69887d93-de9a-4397-a629-a0ce8e62c69a
Gabapentin
Orange BookUNIISPLATC N02BF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCipla USA Inc.
CountryUS (United States)
ATC codeN02BF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11690978120230 TABLET in 1 BOTTLE (69097-812-02)
- ndc116909781207100 TABLET in 1 BOTTLE (69097-812-07)
- ndc116909781212500 TABLET in 1 BOTTLE (69097-812-12)
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": "69097-812_69887d93-de9a-4397-a629-a0ce8e62c69a",
"productndc": "69097-812",
"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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