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United States · US · US:58118-1103_15c4b320-aeb7-6e3b-e063-6294a90a277b
Gabapentin
Orange BookUNIISPLATC N02BF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerClinical Solutions Wholesale, LLC
CountryUS (United States)
ATC codeN02BF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11581181103830 CAPSULE in 1 BLISTER PACK (58118-1103-8)
Annotations
UNII (FDA Substance ID)
6CW7F3G59X
GABAPENTIN
RxCUI 25480
Orange Book
A078428
ABABAB
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": "58118-1103_15c4b320-aeb7-6e3b-e063-6294a90a277b",
"productndc": "58118-1103",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "078428",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "Jul 25, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "002",
"approval_date": "Jul 25, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "003",
"approval_date": "Jul 25, 2007"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GABAPENTIN",
"proprietary_name": "Gabapentin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078428",
"marketing_category": "ANDA",
"nonproprietary_name": "Gabapentin",
"start_marketing_date": "20091124",
"active_numerator_strength": "400"
}Related drugs
Other records sharing ATC code N02BF01.
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