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United States · US · US:76420-235_e347fcb2-dba9-193d-e053-2995a90a4784
Gabapentin
Orange BookUNIISPLATC N02BF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAsclemed USA, Inc.
CountryUS (United States)
ATC codeN02BF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc117642023512120 TABLET in 1 BOTTLE (76420-235-12)
- ndc117642023524240 TABLET in 1 BOTTLE (76420-235-24)
- ndc11764202353030 TABLET in 1 BOTTLE (76420-235-30)
- ndc11764202356060 TABLET in 1 BOTTLE (76420-235-60)
- ndc11764202359090 TABLET in 1 BOTTLE (76420-235-90)
Annotations
UNII (FDA Substance ID)
6CW7F3G59X
GABAPENTIN
RxCUI 25480
Orange Book
A205101
AB1AB1
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": "76420-235_e347fcb2-dba9-193d-e053-2995a90a4784",
"productndc": "76420-235",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "205101",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "600MG",
"product_no": "001",
"approval_date": "Feb 4, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AB1",
"strength": "800MG",
"product_no": "002",
"approval_date": "Feb 4, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GABAPENTIN",
"proprietary_name": "Gabapentin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA205101",
"marketing_category": "ANDA",
"nonproprietary_name": "Gabapentin",
"start_marketing_date": "20160204",
"active_numerator_strength": "600"
}Related drugs
Other records sharing ATC code N02BF01.
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