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United States · US · US:70010-927_36bac528-54ce-1b68-e063-6394a90a0bee
GABAPENTIN
Orange BookUNIISPLATC N02BF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGranules Pharmaceuticals Inc
CountryUS (United States)
ATC codeN02BF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc117001092701100 CAPSULE in 1 BOTTLE (70010-927-01)
- ndc117001092705500 CAPSULE in 1 BOTTLE (70010-927-05)
- ndc1170010927101000 CAPSULE in 1 BOTTLE (70010-927-10)
Annotations
UNII (FDA Substance ID)
6CW7F3G59X
GABAPENTIN
RxCUI 25480
Orange Book
A075360
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": "70010-927_36bac528-54ce-1b68-e063-6394a90a0bee",
"productndc": "70010-927",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "075360",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "Apr 6, 2005"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "002",
"approval_date": "Apr 6, 2005"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "003",
"approval_date": "Apr 6, 2005"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GABAPENTIN",
"proprietary_name": "GABAPENTIN",
"active_ingred_unit": "mg/1",
"application_number": "ANDA075360",
"marketing_category": "ANDA",
"nonproprietary_name": "GABAPENTIN",
"start_marketing_date": "20210901",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code N02BF01.
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