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United States · US · US:67877-428_280c139f-c3a2-46e4-b990-ce3808166e86
Gabapentin
Orange BookUNIISPLATC N02BF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAscend Laboratories, LLC
CountryUS (United States)
ATC codeN02BF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc116787742801100 TABLET in 1 BOTTLE (67877-428-01)
- ndc116787742805500 TABLET in 1 BOTTLE (67877-428-05)
- ndc1167877428101000 TABLET in 1 BOTTLE (67877-428-10)
- ndc116787742838100 BLISTER PACK in 1 CARTON (67877-428-38) / 10 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
6CW7F3G59X
GABAPENTIN
RxCUI 25480
Orange Book
A206402
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": "67877-428_280c139f-c3a2-46e4-b990-ce3808166e86",
"productndc": "67877-428",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "206402",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "600MG",
"product_no": "001",
"approval_date": "Dec 23, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "800MG",
"product_no": "002",
"approval_date": "Dec 23, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GABAPENTIN",
"proprietary_name": "Gabapentin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA206402",
"marketing_category": "ANDA",
"nonproprietary_name": "Gabapentin",
"start_marketing_date": "20151101",
"active_numerator_strength": "600"
}Related drugs
Other records sharing ATC code N02BF01.
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