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United States · US · US:68788-8563_561b2673-98f8-484f-88a7-0bc7e46314eb
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
- ndc116878885631100 CAPSULE in 1 BOTTLE, PLASTIC (68788-8563-1)
- ndc11687888563330 CAPSULE in 1 BOTTLE, PLASTIC (68788-8563-3)
- ndc11687888563660 CAPSULE in 1 BOTTLE, PLASTIC (68788-8563-6)
- ndc116878885638120 CAPSULE in 1 BOTTLE, PLASTIC (68788-8563-8)
- ndc11687888563990 CAPSULE in 1 BOTTLE, PLASTIC (68788-8563-9)
Annotations
UNII (FDA Substance ID)
6CW7F3G59X
GABAPENTIN
RxCUI 25480
Orange Book
A204989
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": "68788-8563_561b2673-98f8-484f-88a7-0bc7e46314eb",
"productndc": "68788-8563",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "204989",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "Feb 18, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "002",
"approval_date": "Feb 18, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "003",
"approval_date": "Feb 18, 2016"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "200MG",
"product_no": "004",
"approval_date": "Mar 6, 2026"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GABAPENTIN",
"proprietary_name": "Gabapentin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA204989",
"marketing_category": "ANDA",
"nonproprietary_name": "Gabapentin",
"start_marketing_date": "20240110",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code N02BF01.
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