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United States · US · US:71205-064_20a670b9-5238-4bbc-b23f-b3e56d5b34ab
Gabapentin
Orange BookUNIISPLATC N02BF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeN02BF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11712050643030 CAPSULE in 1 BOTTLE (71205-064-30)
- ndc11712050646060 CAPSULE in 1 BOTTLE (71205-064-60)
- ndc117120506472120 CAPSULE in 1 BOTTLE (71205-064-72)
- ndc11712050649090 CAPSULE in 1 BOTTLE (71205-064-90)
Annotations
UNII (FDA Substance ID)
6CW7F3G59X
GABAPENTIN
RxCUI 25480
Orange Book
A075350
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": "71205-064_20a670b9-5238-4bbc-b23f-b3e56d5b34ab",
"productndc": "71205-064",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "075350",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "Sep 12, 2003"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "002",
"approval_date": "Sep 12, 2003"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "003",
"approval_date": "Sep 12, 2003"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GABAPENTIN",
"proprietary_name": "Gabapentin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA075350",
"marketing_category": "ANDA",
"nonproprietary_name": "Gabapentin",
"start_marketing_date": "20140403",
"active_numerator_strength": "400"
}Related drugs
Other records sharing ATC code N02BF01.
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