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United States · US · US:68788-8199_7797ee73-8a7b-4cb0-aa70-ed3b94aab693
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
- ndc116878881991100 CAPSULE in 1 BOTTLE, PLASTIC (68788-8199-1)
- ndc11687888199330 CAPSULE in 1 BOTTLE, PLASTIC (68788-8199-3)
- ndc11687888199660 CAPSULE in 1 BOTTLE, PLASTIC (68788-8199-6)
- ndc116878881998120 CAPSULE in 1 BOTTLE, PLASTIC (68788-8199-8)
- ndc11687888199990 CAPSULE in 1 BOTTLE, PLASTIC (68788-8199-9)
Annotations
UNII (FDA Substance ID)
6CW7F3G59X
GABAPENTIN
RxCUI 25480
Orange Book
A206943
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": "68788-8199_7797ee73-8a7b-4cb0-aa70-ed3b94aab693",
"productndc": "68788-8199",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "206943",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "May 14, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "002",
"approval_date": "May 14, 2018"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "003",
"approval_date": "May 14, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GABAPENTIN",
"proprietary_name": "Gabapentin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA206943",
"marketing_category": "ANDA",
"nonproprietary_name": "Gabapentin",
"start_marketing_date": "20220523",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code N02BF01.
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