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United States · US · US:76282-627_5e0a57d7-9068-43d3-be26-96f646720fde
GABAPENTIN
Orange BookUNIISPLATC N02BF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerExelan Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN02BF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 7
- ndc117628262701100 CAPSULE in 1 BOTTLE (76282-627-01)
- ndc117628262705500 CAPSULE in 1 BOTTLE (76282-627-05)
- ndc117628262718180 CAPSULE in 1 BOTTLE (76282-627-18)
- ndc117628262727270 CAPSULE in 1 BOTTLE (76282-627-27)
- ndc11762826273030 CAPSULE in 1 BOTTLE (76282-627-30)
- ndc11762826276060 CAPSULE in 1 BOTTLE (76282-627-60)
- ndc11762826279090 CAPSULE in 1 BOTTLE (76282-627-90)
Annotations
UNII (FDA Substance ID)
6CW7F3G59X
GABAPENTIN
RxCUI 25480
Orange Book
A090705
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": "76282-627_5e0a57d7-9068-43d3-be26-96f646720fde",
"productndc": "76282-627",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "090705",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "Dec 30, 2009"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "002",
"approval_date": "Dec 30, 2009"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "003",
"approval_date": "Dec 30, 2009"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GABAPENTIN",
"proprietary_name": "GABAPENTIN",
"active_ingred_unit": "mg/1",
"application_number": "ANDA090705",
"marketing_category": "ANDA",
"nonproprietary_name": "GABAPENTIN",
"start_marketing_date": "20180913",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code N02BF01.
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