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United States · US · US:68788-8790_b0ca9e97-d218-4ec2-9b59-575cbc5b7d35
GABAPENTIN
Orange BookUNIISPLATC N02BF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeN02BF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc116878887901100 TABLET in 1 BOTTLE (68788-8790-1)
- ndc11687888790330 TABLET in 1 BOTTLE (68788-8790-3)
- ndc11687888790660 TABLET in 1 BOTTLE (68788-8790-6)
- ndc116878887908120 TABLET in 1 BOTTLE (68788-8790-8)
- ndc11687888790990 TABLET in 1 BOTTLE (68788-8790-9)
Annotations
UNII (FDA Substance ID)
6CW7F3G59X
GABAPENTIN
RxCUI 25480
Orange Book
A214957
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": "68788-8790_b0ca9e97-d218-4ec2-9b59-575cbc5b7d35",
"productndc": "68788-8790",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "214957",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "600MG",
"product_no": "001",
"approval_date": "Oct 1, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "800MG",
"product_no": "002",
"approval_date": "Oct 1, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GABAPENTIN",
"proprietary_name": "GABAPENTIN",
"active_ingred_unit": "mg/1",
"application_number": "ANDA214957",
"marketing_category": "ANDA",
"nonproprietary_name": "Gabapentin",
"start_marketing_date": "20241216",
"active_numerator_strength": "800"
}Related drugs
Other records sharing ATC code N02BF01.
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