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United States · US · US:16714-661_2f6c168b-aaf3-4a6a-b8a0-5be6b5f81d7e
Gabapentin
Orange BookUNIISPLATC N02BF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNorthStar Rx LLC
CountryUS (United States)
ATC codeN02BF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc111671466101100 CAPSULE in 1 BOTTLE (16714-661-01)
- ndc111671466102500 CAPSULE in 1 BOTTLE (16714-661-02)
- ndc1116714661031000 CAPSULE in 1 BOTTLE (16714-661-03)
Annotations
UNII (FDA Substance ID)
6CW7F3G59X
GABAPENTIN
RxCUI 25480
Orange Book
A078787
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": "16714-661_2f6c168b-aaf3-4a6a-b8a0-5be6b5f81d7e",
"productndc": "16714-661",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "078787",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "Jan 31, 2008"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "002",
"approval_date": "Jan 31, 2008"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "003",
"approval_date": "Jan 31, 2008"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GABAPENTIN",
"proprietary_name": "Gabapentin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078787",
"marketing_category": "ANDA",
"nonproprietary_name": "Gabapentin",
"start_marketing_date": "20080131",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code N02BF01.
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