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United States · US · US:80425-0033_4d628103-5e90-0a21-e063-6394a90a484e
Gabapentin
Orange BookUNIISPLATC N02BF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAdvanced Rx of Tennessee, LLC
CountryUS (United States)
ATC codeN02BF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc11804250033130 CAPSULE in 1 BOTTLE (80425-0033-1)
- ndc11804250033260 CAPSULE in 1 BOTTLE (80425-0033-2)
- ndc11804250033390 CAPSULE in 1 BOTTLE (80425-0033-3)
- ndc11804250033440 CAPSULE in 1 BOTTLE (80425-0033-4)
- ndc118042500335120 CAPSULE in 1 BOTTLE (80425-0033-5)
- ndc1180425003369 CAPSULE in 1 BOTTLE (80425-0033-6)
Annotations
UNII (FDA Substance ID)
6CW7F3G59X
GABAPENTIN
RxCUI 25480
Orange Book
A090858
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": "80425-0033_4d628103-5e90-0a21-e063-6394a90a484e",
"productndc": "80425-0033",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "090858",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "Dec 17, 2010"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "002",
"approval_date": "Dec 17, 2010"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "003",
"approval_date": "Dec 17, 2010"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GABAPENTIN",
"proprietary_name": "Gabapentin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA090858",
"marketing_category": "ANDA",
"nonproprietary_name": "Gabapentin",
"start_marketing_date": "20110129",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code N02BF01.
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